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Werfen Ltd

Authorized Representative in the United Kingdom

712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester

Manchester, England, United Kingdom

Postcode: WA3 6DE

Relationship Type: UK Responsible Person
462 Products Represented
12 Manufacturers
Total Products
462
Manufacturers
12
Device Types
3
Generic Names
399
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (462)
Complete portfolio registered with MHRA

Aspergillus fumigatus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tropheryma whipplei nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple bloodstream bacteria nucleic acid IVD, control

Manufacturer:

T2 Biosystems Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida species nucleic acid IVD, control

Manufacturer:

T2 Biosystems Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

T2 Biosystems Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated clotting time (ACT) IVD, reagent

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Co-oximetry analyser IVD, point-of-care

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory, semi-automated

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation analyser IVD

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation analyser IVD

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum reagin antibody IVD, kit, agglutination

Manufacturer:

Arlington Scientific, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor X IVD, control

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, agglutination

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, agglutination

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digitoxin therapeutic drug monitoring IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, nephelometry/turbidimetry

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen degradation product (FDP) IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen degradation product (FDP) IVD, control

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General laboratory container, single-use

Manufacturer:

BIOKIT S.A.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, nephelometry/turbidimetry

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Test tube/reservoir cap

Manufacturer:

BIOKIT S.A.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

von Willebrand factor: collagen binding activity (vWF:CBA) IVD, reagent

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, kit, multiplex

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ADAMTS13 activity IVD, kit, chemiluminescent immunoassay

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-2-antiplasmin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin-B2-glycoprotein I complex antibody IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barcode reader

Manufacturer:

Instrumentation Laboratory Co

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) IVD, reagent

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor V IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor Xa inhibitor IVD, calibrator

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XII IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited thrombophilia IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser test tube rack adaptor IVD

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lupus anticoagulant marker IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas analyte IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasminogen IVD, kit, chromogenic

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, calibrator

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hu antibody (anti-Hu) IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser cleaning agent IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Jo-1 antibody IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Jo-1 antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitochondrial antibody M2 (anti-Mi2) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ro52?antibody?(anti-Ro52)/TRIM21?antibody?IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smith antibody (anti-Sm) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smith antibody (anti-Sm) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smooth muscle antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sp-100 protein antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiplex analyser IVD, laboratory, automated

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleosomal antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phosphatidylserine/prothrombin complex antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ro52 antibody (anti-Ro52)/Trim21 antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Culture tube

Manufacturer:

BIOKIT S.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

D-dimer IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General laboratory container, single-use

Manufacturer:

BIOKIT S.A.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Instrument/analyser test tube rack adaptor IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser test tube rack adaptor IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser rinse fluid tank IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, kit, nephelometry/turbidimetry

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, agglutination

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Test tube/reservoir cap

Manufacturer:

BIOKIT S.A.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chikungunya virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium tetani immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coxiella burnetii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Schistosoma mansoni immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, kit, spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, manual

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, calibrator

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urea IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood gas/haemoximetry analyser IVD, laboratory

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood gas/haemoximetry analyser IVD, laboratory

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, manual

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VII IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, kit, chromogenic

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor Xa inhibitor IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Direct thrombin inhibitor therapeutic drug monitoring IVD, calibrator

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aspergillus fumigatus nucleic acid IVD, calibrator

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, reagent

Manufacturer:

T2 Biosystems Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chikungunya virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hantavirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hantavirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza B virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Brucella species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple helminth total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human parainfluenza virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Leishmania species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Schistosoma mansoni immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tick-borne encephalitis (TBE) virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acetylcholinesterase IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, kit, spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple apolipoprotein IVD, calibrator

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, kit, spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood bank centrifuge

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Column agglutination IVD

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory liquid dispenser, manual

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood lancet, single-use

Manufacturer:

Accriva Diagnostics

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation analyser IVD

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antithrombin III (ATIII) IVD, kit, chromogenic

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, manual

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor IX IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XI IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor XIII A subunit IVD, kit, nephelometry/turbidimetry

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, agglutination

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Direct thrombin inhibitor therapeutic drug monitoring IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, calibrator

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, kit, chromogenic

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle liner IVD

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas analyte IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, calibrator

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet factor 4 IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet factor 4-heparin complex antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein C IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein S IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein S IVD, kit, nephelometry/turbidimetry

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red blood cell count IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenal antibody IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-glycoprotein I antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double?stranded?DNA?antibody (anti-dsDNA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycoprotein-210 (gp210) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intrinsic factor/parietal cell antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Jo-1 antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscopy mounting medium IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple diabetes mellitus-associated antibody IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiplex analyser IVD, laboratory

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiplex analyser IVD, laboratory, automated

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myelin-associated glycoprotein antibody (anti-MAG) IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polymyositis-scleroderma antibody (anti-PM-Scl) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polymyositis-scleroderma antibody (anti-PM-Scl) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sm/RNP antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ri antibody (anti-Ri) IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Scleroderma-70 antibody (anti-Scl-70) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skeletal muscle antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skeletal muscle antibody IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sm/RNP antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smith antibody (anti-Sm) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSA/Ro antibody (Sjogren's antibody) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSB/La antibody (Sjogren's antibody) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSB/La antibody (Sjogren's antibody) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Yo antibody IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General laboratory container, single-use

Manufacturer:

Instrumentation Laboratory Co

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple electrolyte IVD, control

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protein C IVD, kit, chromogenic

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thrombin time (TT) IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell morphology analyser IVD, manual

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell morphology analyser IVD, manual

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement component C1q IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endomysium antibody (EMA) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endomysium antibody (EMA) IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohistochemistry conjugated secondary antibody IVD

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intrinsic factor/parietal cell antibody IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple myocardium antibody IVD, reagent

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ribosomal phosphoprotein antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ro52 antibody (anti-Ro52)/Trim21 antibody IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Scleroderma-70 antibody (anti-Scl-70) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Scleroderma-70 antibody (anti-Scl-70) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skin antibody IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sm/RNP antibody IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smooth muscle antibody IVD, kit, fluorescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSA/Ro antibody (Sjogren's antibody) IVD, calibrator

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSA/Ro antibody (Sjogren's antibody) IVD, control

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSB/La antibody (Sjogren's antibody) IVD, kit, chemiluminescent immunoassay

Manufacturer:

INOVA Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, manual

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digitoxin therapeutic drug monitoring IVD, control

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen degradation product (FDP) IVD, kit, agglutination

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, control

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, control

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin E (IgE total) IVD, calibrator

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOKIT S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple haemoximetry analyte IVD, control

Manufacturer:

Bionostics, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, reagent

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory, semi-automated

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas analyte IVD, reagent

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, reagent

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation study IVD, reagent

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, reagent

Manufacturer:

Accriva Diagnostics

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-K (KEL001) red blood cell grouping IVD, antibody

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida albicans immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple electrolyte IVD, calibrator

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple electrolyte IVD, reagent

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, kit, spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, kit, enzyme spectrophotometry

Manufacturer:

Instrumentation Laboratory SpA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Progenie Molecular SLU

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnetic particle separation instrument IVD

Manufacturer:

T2 Biosystems Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

T2 Biosystems Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium chloride coagulation reagent IVD

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory, semi-automated

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, kit, clotting

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, kit, clotting

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thromboelastrometry parameter IVD, kit, clotting

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation study IVD, reagent

Manufacturer:

Tem Innovations GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Direct thrombin inhibitor therapeutic drug monitoring IVD, kit, clotting

Manufacturer:

Instrumentation Laboratory Co

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ABO/Rh multiple blood grouping IVD, kit, agglutination

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ABO/Rh(D)/IgG multiple blood grouping IVD, kit, agglutination

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aerobic laboratory incubator

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Immunoglobulin-sensitized reagent red blood cell IVD, control

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohaematology/blood bank analyser IVD

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mechanical micropipette IVD

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

Manufacturer:

Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, reagent

Manufacturer:

Gold Standard Diagnostics Frankfurt GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

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

Last updated: December 2025