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Roche Diagnostics Limited

Authorized Representative in the United Kingdom

Roche Diagnostics Limited Charles Avenue

Burgess Hill, United Kingdom

Postcode: RH15 9RY

Relationship Type: UK Responsible Person
1271 Products Represented
6 Manufacturers
Total Products
1271
Manufacturers
6
Device Types
2
Generic Names
744
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (1271)
Complete portfolio registered with MHRA

Cancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus antibody/antigen IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus genotyping IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human epididymis protein 4 (HE4) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human growth hormone (HGH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry wash buffer reagent IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser test tube rack adaptor IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ion selective electrode (ISE) reference solution IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ion-selective analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain messenger RNA IVD, probe

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser absorbent liner IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactate IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lithium electrode IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lysergic acid diethylamide (LSD)/LSD metabolite IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Macrophage inhibitory cytokine 1/growth-differentiation factor 15 (MIC-1/GDF15) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mesothelin IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Metabolic profile clinical chemistry analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Metabolic profile clinical chemistry analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methaqualone IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MLH1 protein IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MSH6 antigen IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multi-modality clinical specimen analysis system IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multi-modality clinical specimen analysis system IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Mycobacterium species nucleic acid IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Mycobacterium species nucleic acid IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple therapeutic drugs/drugs of abuse IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple therapeutic drugs/drugs of abuse IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tissue-associated protein/tumour marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-therapy therapeutic drug monitoring IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycophenolate therapeutic drug monitoring IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycophenolate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycophenolate therapeutic drug monitoring IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myosin light chain IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

N-acetylprocainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification mastermix kit IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid hybridization detection IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p16 antigen IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p53 tumour protein antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PIK3CA gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Placental growth factor (PLGF) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Placental growth factor (PLGF) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Potassium (K+) IVD, kit, ion-selective electrode (ISE)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregnancy-associated plasma protein A (PAPP-A) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregnancy-associated plasma protein A (PAPP-A) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregnancy-associated plasma protein A (PAPP-A) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Primidone therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procollagen type I N-terminal propeptide (PINP) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progastrin-releasing peptide (ProGRP) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progastrin-releasing peptide (ProGRP) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progastrin-releasing peptide (ProGRP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein S IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reference electrode IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella?virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100 protein IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100 protein IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Salicylate IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sex hormone binding globulin (SHBG) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Squamous cell carcinoma antigen IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Syringe/blood collection tube adaptor IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tacrolimus therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tacrolimus?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone receptor (TSHR) antibody IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid uptake (T-uptake) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tobramycin?therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bilirubin IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total/prostatic acid phosphatase (TcP) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T/Troponin I IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T/Troponin I IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Valproic acid therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus nucleic acid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Basic/simple nutrient broth culture medium IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dried plasma spot collection card IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Exogenous DNA/RNA internal control IVD, kit

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A/Parvovirus B19 virus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory container/microscope slide robotic transfer system IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-evacuated urine specimen container IVD, no additive

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid hybridization detection IVD, kit

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

Roche Molecular Systems Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Test tube/reservoir cap IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-fibrinogen mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Familial hypercholesterolaemia IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hereditary haemochromatosis IVD, primer

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human parainfluenza virus 2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human parechovirus (HPeV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MERS-CoV nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal virus nucleic acid IVD, reagent

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin K epoxide reductase complex subunit-1 (VKORC1) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

25-Hydroxy vitamin D3 IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

25-Hydroxy vitamin D3 IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, kit, rapid clotting, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-hydroxybutyrate dehydrogenase IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amikacin therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine-specific IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine/methamphetamine group IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine/methamphetamine group IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amylase isoenzyme IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androstenedione IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antithrombin III (ATIII) IVD, kit, chromogenic

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood gas pH IVD, kit, ion-selective electrode (ISE)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood gas pO2 IVD, kit, ion-selective electrode (ISE)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcitonin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium (Ca2+) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium (Ca2+) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium chloride coagulation reagent IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 15-3 (CA15-3) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 19-9 (CA19-9) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 72-4 (CA72-4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 72-4 (CA72-4) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chromogen indicator IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cholinesterase dibucaine number (percentage inhibition) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cholinesterase dibucaine number (percentage inhibition) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chromogen indicator IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory, semi-automated

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VII IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor X IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor X IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen type I cross-linked C-telopeptide IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytokeratin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytokeratin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytokeratin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytokeratin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Des-gamma-carboxyprothrombin (DCP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digitoxin?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digoxin therapeutic drug monitoring IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol (oestradiol) (E2) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol?(oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol?(oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate (vitamin B9) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free triiodothyronine (FT3) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose analyser IVD, point-of-care

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glutamate dehydrogenase IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XIII mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fructose/lactose intolerance IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human metapneumovirus (hMPV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human parainfluenza virus 3 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ion-selective analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acetaminophen IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acetaminophen IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acetaminophen IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ammonia IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine-specific IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amylase isoenzyme IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplastic lymphoma kinase IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antithrombin III (ATIII) IVD, kit, chromogenic

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container insert tube IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood gas analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-erbB2/Her2/neu oncoprotein IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-peptide IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcitonin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium chloride coagulation reagent IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 15-3 (CA15-3) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 72-4 (CA72-4) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer risk assessment interpretive software IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbon dioxide (CO2) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chloride (Cl-) electrode IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical management support software IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, point-of-care, battery-powered

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VII IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen type I cross-linked C-telopeptide IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclosporin A/cyclosporine?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytology specimen container IVD, transport buffer

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) nucleic acid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digitoxin therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digitoxin?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digoxin therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol (oestradiol) (E2) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate (vitamin B9) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fructosamine IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fructosamine IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Full blood count IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General laboratory assay tray

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose analyser IVD, point-of-care

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, kit, enzyme spectrophotometry, rapid

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose/ketone/lipid monitoring system IVD, home-use

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haptoglobin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, kit, chromogenic

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, kit, chromogenic

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A/Parvovirus B19 virus nucleic acid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen/antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus nucleic acid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Holotranscobalamin (holoTC) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Holotranscobalamin (holoTC) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Holotranscobalamin (holoTC) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human epididymis protein 4 (HE4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) nucleic acid IVD, probe

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser test tube rack adaptor IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ion selective electrode (ISE) reference solution IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ion selective electrode (ISE) reference solution IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Iron IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Isotonic saline reagent IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

KRAS gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

KRAS gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactate IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipase IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lithium therapeutic drug monitoring IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chikungunya virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human parainfluenza virus 1 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple enterovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus sexually transmitted bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Viral inactivation buffer IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Viral inactivation buffer IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B12 IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B12 IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B12 IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B6 complex group IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

25-Hydroxy vitamin D3 IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acetaminophen IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acetylcholinesterase IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, kit, rapid clotting, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-hydroxybutyrate dehydrogenase IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amikacin therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ammonia IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androstenedione IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androstenedione IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androstenedione IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay adhesive sealing/fixation film IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container insert tube IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-peptide IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 72-4 (CA72-4) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbamazepine therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbon dioxide (CO2) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chloride (Cl-) electrode IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cholinesterase dibucaine number (percentage inhibition) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Claudin protein IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory, semi-automated

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, point-of-care, battery-powered

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, point-of-care, battery-powered

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclosporin A/cyclosporine?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytology specimen container IVD, transport buffer

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Delta-like protein 3 (DLL3) IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Des-gamma-carboxyprothrombin (DCP) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Des-gamma-carboxyprothrombin (DCP) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digitoxin therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digoxin therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dried plasma spot collection card IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin?IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin?IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate (vitamin B9) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate (vitamin B9) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate?(vitamin B9) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate?(vitamin B9) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free testosterone IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free testosterone IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose analyser IVD, point-of-care

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haptoglobin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human epididymis protein 4 (HE4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human epididymis protein 4 (HE4) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hyaluronic acid (HA) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Iron IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Isotonic saline reagent IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle liner IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle liner IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactate IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactate IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lidocaine therapeutic drug monitoring IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipase IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lithium therapeutic drug monitoring IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methotrexate therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate/cuvette holder IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate/cuvette holder IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multi-modality clinical specimen analysis system IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas analyte IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas analyte IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory, semi-automated

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry protein IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple electrolyte IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

TIB Molbiol Syntheselabor Gmbh

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Mycobacterium species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Mycobacterium species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple therapeutic drugs/drugs of abuse IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tissue-associated protein/tumour marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-therapy therapeutic drug monitoring IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type tropical pathogen nucleic acid IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycophenolate therapeutic drug monitoring IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p16 antigen IVD, antibody

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p53 tumour protein antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PCR/NAT negative control IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PCR/NAT negative control IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phenobarbital therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phenytoin therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation study IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procollagen type I N-terminal propeptide (PINP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procollagen type I N-terminal propeptide (PINP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progastrin-releasing peptide (ProGRP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein C IVD, kit, chromogenic

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, kit, rapid clotting, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Quinidine therapeutic?drug monitoring?IVD, kit,?nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reference electrode IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100 protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100 protein IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Salicylate IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Single-channel clinical chemistry analyser IVD, point-of-care

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sodium (Na+) electrode IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Squamous cell carcinoma antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Test tube/reservoir cap IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thrombin time (TT) IVD, kit, clotting

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid uptake (T-uptake) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total amylase IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bilirubin IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bilirubin IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T/Troponin I IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine protein IVD, kit, rapid colorimetric, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vancomycin therapeutic?drug monitoring?IVD, kit,?nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

West Nile virus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, nucleic acid stabilizer

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, additive/medium

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, additive/medium

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA/MSSA nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA/MSSA nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human parainfluenza virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunocompromised host infection-associated virus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Plasmodium species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Slide-mounted-tissue dissection system IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen processing instrument IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine specimen collection kit IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Macrophage inhibitory cytokine 1/growth-differentiation factor 15 (MIC-1/GDF15) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnesium (Mg2+) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnesium (Mg2+) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methaqualone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methaqualone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Morphine/morphine metabolite IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Morphine/morphine metabolite IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry protein IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid antibody IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid marker IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type tropical pathogen nucleic acid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycophenolate therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myosin light chain IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

N-acetylprocainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-blood cell primer/calibrator/control material IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osteocalcin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osteocalcin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

p53 tumour protein antibody IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PCR/NAT negative control IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phenobarbital therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PIK3CA gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation study IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Potassium (K+) IVD, kit, ion-selective electrode (ISE)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Potassium (K+) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregnancy-associated plasma protein A (PAPP-A) IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procollagen type I N-terminal propeptide (PINP) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Quinidine therapeutic?drug monitoring?IVD, kit,?nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella?virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Salicylate IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sex hormone binding globulin (SHBG) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sodium (Na+) electrode IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen processing instrument IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen processing instrument IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Squamous cell carcinoma antigen IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Squamous cell carcinoma antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Syringe/blood collection tube adaptor IVD

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tacrolimus therapeutic drug monitoring IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tacrolimus?therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone receptor (TSHR) antibody IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tobramycin?therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total alkaline phosphatase (ALP) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total amylase IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bilirubin IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total/prostatic acid phosphatase (TcP) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, kit, rapid ICT, clinical

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T/Troponin I IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi total antibody IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urea IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urea IVD, kit, enzyme spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, kit, spectrophotometry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vancomycin therapeutic?drug monitoring?IVD, kit,?nephelometry/turbidimetry

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B12 IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B6 complex group IVD, reagent

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

West Nile virus nucleic acid IVD, control

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump software, patient-dosing

Manufacturer:

mySugr GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

mySugr GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

mySugr GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PCR/NAT negative control IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PCR/NAT negative control IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Slide-mounted-tissue dissection system IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen processing instrument IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine specimen collection kit IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay adhesive sealing/fixation film IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Exogenous DNA/RNA internal control IVD, kit

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Molecular grade procedure oil IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA phenotype detection IVD, kit, bioassay

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunocompromised host infection-associated virus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Plasmodium species nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, reagent

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, control

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-evacuated urine specimen container IVD, no additive

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification mastermix kit IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD, semi-automated

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, single-use

Manufacturer:

Roche Molecular Systems Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 23, 2024

Nucleic acid hybridization detection IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Nucleic acid hybridization detection IVD, kit

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p40 protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p504s protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p53 tumour protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p63 tumour protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p63 tumour protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Progesterone receptor IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Proliferating cell nuclear antigen (PCNA) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Proliferating cell nuclear antigen (PCNA) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Prostate-specific membrane antigen (PSMA) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Thyroid transcription factor-1 (TTF1) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Topoisomerase IIa IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Tyrosinase IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Albumin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Alpha-catenin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

B-cell specific activator protein (BSAP) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Basal cell cocktail IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Buffered wash solution IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

C-erbB2/Her2/neu oncoprotein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

c-MYC proto-oncogene protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Cadherin protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Carcinoembryonic antigen (CEA) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD10 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD10 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD117 (c-kit) cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD15 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD20 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD3 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD34 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD34 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD44 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD45 leukocyte common antigen cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD45 leukocyte common antigen cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD5 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD5 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD68 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD79a cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD79a cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD8 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD99 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Chromogranin A IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Cytokeratin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Differentiation solution IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epidermal growth factor receptor (EGFR) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epithelial-related antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epithelial-related antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Fibrinogen (Factor I) assay IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Fibrinogen (Factor I) assay IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Hepatocyte growth factor (HGF) IVD, reagent

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry antibody diluent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry protease reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry signal amplification reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

MSH2 antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Multiple tissue-associated protein/tumour marker IVD, reagent

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

ETS-related gene (ERG) protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Helicobacter pylori antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Histology/cytology/microbiology image-analysis interpretive software IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry conjugated secondary antibody IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry conjugated secondary antibody IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry endogenous protein blocking reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry signal amplification reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Kappa/lambda light chain messenger RNA IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

MSH6 antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Mucin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Mucin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Multiple tissue-associated protein/tumour marker IVD, reagent

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Bcl-2 oncoprotein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Bcl-2 oncoprotein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Biological stain IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Estrogen (oestrogen)/progesterone receptor IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Melanosome IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microphthalmia-associated transcription factor (MITF) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microscope slide coverslip IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microscope slide coverslip IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

MLH1 protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Estrogen (oestrogen)/progesterone receptor IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Negative control immunoglobulin IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Negative control immunoglobulin IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Nucleic acid hybridization detection IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Nucleic acid hybridization detection IVD, reagent

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p16 antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p16 antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p40 protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p504s protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p53 tumour protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Phosphatase and tensin homolog (PTEN) protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

S100 protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Thyroid transcription factor-1 (TTF1) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Topoisomerase IIa IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Tropomyosin receptor kinase (TRK) protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Vimentin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Xylene solution substitute IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Alpha-catenin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Basal cell cocktail IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Desmin protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Differentiation solution IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epithelial membrane antigen (EMA) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epithelial membrane antigen (EMA) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

BRAF V600 gene mutation IVD, reagent

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

C-erbB2/Her2/neu oncoprotein IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

c-MYC proto-oncogene protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Calretinin protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD15 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD22 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Nucleic acid hybridization detection IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Nucleic acid hybridization detection IVD, kit

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Nucleic acid hybridization detection IVD, probe

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Nucleic acid hybridization detection IVD, reagent

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p504s protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

p53 tumour protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Phosphatase and tensin homolog (PTEN) protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Postmeiotic segregation increased 2 (PMS2) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Progesterone receptor IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Programmed death-ligand 1 (PD-L1) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

S100 protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Slide-mounted-tissue dissection system IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Smooth muscle actin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Synaptophysin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Synaptophysin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Tumour necrosis factor receptor superfamily IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Tumour necrosis factor receptor superfamily IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Tyrosinase IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Vimentin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Xylene solution substitute IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Anaplastic lymphoma kinase IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Assay container IVD, single-use

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

B-cell specific activator protein (BSAP) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Biological stain IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Biological stain IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

C-erbB2/Her2/neu oncoprotein IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Cadherin protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Calretinin protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD117 (c-kit) cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD20 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD23 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD23 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD3 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD4 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD43 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD56 neural cell adhesion molecule-1 (NCAM-1) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD7 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD7 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD8 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Chromogranin A IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Complement component C1q IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Complement component C1q IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Complement components C3/C3c IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Cyclin D1 IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Cyclin D1 IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Cytokeratin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Desmin protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, reagent

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

ETS-related gene (ERG) protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Helicobacter pylori antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Human papillomavirus (HPV) nucleic acid IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry antibody diluent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Immunohistochemistry protease reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Kappa/lambda light chain immunoglobulin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Kappa/lambda light chain immunoglobulin IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Kappa/lambda light chain messenger RNA IVD, control

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Kappa/lambda light chain messenger RNA IVD, probe

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Melan-A/MART-1 peptide IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Melanoma specific protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Melanosome IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microphthalmia-associated transcription factor (MITF) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microscope slide stainer IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Microscope slide stainer IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD4 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD43 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD45RO cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD68 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

CD99 cell marker IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Complement components C3/C3c IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Ki67 antigen IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Melan-A/MART-1 peptide IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Melanoma specific protein IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 15, 2024

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Roche Sequencing Solutions, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 1, 2024

Human genomic analysis interpretive software

Manufacturer:

Roche Sequencing Solutions, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 1, 2024

Prostate-specific membrane antigen (PSMA) IVD, antibody

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 9, 2024

Self-care monitoring/reporting software

Manufacturer:

Roche Molecular Systems Inc.

Type:

General Medical Device

Registration Date:

Apr 22, 2021

Follicle stimulating hormone (FSH) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Thyroglobulin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Calcitonin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Calcitonin IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Troponin T IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Cancer antigen 72-4 (CA72-4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Free thyroxine (FT4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Free thyroxine (FT4) IVD, calibrator

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Total testosterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Roche Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 19, 2021

Immunohistochemistry endogenous avidin/biotin dual blocking reagent IVD

Manufacturer:

Ventana Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 26, 2021

Data sourced from the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

Last updated: December 2025