Pure Global
Home/UK Database/Authorized Representative
🇬🇧

BIO-RAD LABORATORIES LIMITED

Authorized Representative in the United Kingdom

The Junction 3rd And 4th Floor, Station Road, Watford, United Kingdom, WD17 1ET

WATFORD, England, United Kingdom

Postcode: wd17 1et

Relationship Type: UK Responsible Person
421 Products Represented
10 Manufacturers
Total Products
421
Manufacturers
10
Device Types
1
Generic Names
288
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (421)
Complete portfolio registered with MHRA

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Native DNA antibody (anti-nDNA) IVD, reagent

Manufacturer:

Bio-Rad Laboratories Seattle Operations Redmond

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vasculitis-associated antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum reagin antibody IVD, reagent

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitochondrial antibody M2 (anti-Mi2) IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood-borne virus antigen/antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry protein IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple heavy metal IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reticulocyte count IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smooth muscle antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ABO/Rh multiple blood grouping IVD, kit, agglutination

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-B red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH002] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C^w red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-CDE red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH003] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Kp^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Le^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Le^b red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-N red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Rh(D) red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Rh(D) red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS004] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bovine serum albumin (BSA) immunohaematology reagent IVD

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bovine serum albumin (BSA) immunohaematology reagent IVD

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement components C4/C4c IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Group A2 Rh (D) negative reagent red blood cell IVD, antigen

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Group AB serum IVD, control

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

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:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bacitracin differentiation disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Basic/simple nutrient agar culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida species mannan antigen IVD, reagent

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulase production microbial reagent IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Differential/selective agar culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Differential/selective agar culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enriched broth culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fungal antimicrobial susceptibility culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus antibody/antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 antibody IVD, kit, immunoblot

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, immunoblot

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate/tube/assay card incubator IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple bacteria carbapenemase production IVD, kit, chromogenic

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Brucella species immunoglobulin M (IgM) antibody IVD, reagent

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^a red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^b red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^b red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Lu^b red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-M red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Rh(D) red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS003] red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibody screening reagent red blood cell IVD, kit, agglutination

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell preservation/storage/dilution solution IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Column agglutination IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement coated reagent red blood cell IVD, control

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Duffy (Fy^a & Fy^b) multiple blood grouping IVD, kit, agglutination

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohaematology/blood bank analyser IVD, semi-automated

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser operation system software IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Papain immunohaematology reagent IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

Manufacturer:

Bio-Rad Laboratories, Inc. (DBG - Digital Biology Group)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, control

Manufacturer:

Exact Diagnostics LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1C) analyser IVD

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin F (HbF) IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited haemoglobinopathy IVD, reagent

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phospholipid antibody IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

Manufacturer:

LIfe Science Group

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories Seattle Operations Redmond

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Bio-Rad Laboratories, Inc. (DBG - Digital Biology Group)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell washer IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH005] red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^a red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Le^a red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Le^b red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-N red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Rh(D) red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS004] red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibody identification panel reagent red blood cell IVD, kit, agglutination

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antisera matrix (non-reactive) IVD, control

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bovine serum albumin (BSA) immunohaematology reagent IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell washer IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose centrifuge IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Group A1 Rh (D) positive reagent red blood cell IVD, antigen

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Group B Rh(D) negative reagent red blood cell IVD, antigen

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohaematology/blood bank analyser IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser operation system software IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate/tube/assay card incubator IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Partial (variant) Rh(D) multiple blood grouping IVD, kit, agglutination

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyspecific antihuman globulin/complement IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell antibody diluent IVD, reagent

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, control

Manufacturer:

Exact Diagnostics LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) nucleic acid IVD, control

Manufacturer:

Exact Diagnostics LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^b red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, reagent

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vasculitis-associated antibody IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethanol (ETOH) IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin A2 (HbA2) IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 antigen IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple therapeutic drugs/drugs of abuse IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-AB red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH002] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH004] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH004] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH003] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH005] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^b red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Lu^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Lu^b red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-M red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Wr^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Xg^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antisera matrix (non-reactive) IVD, control

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bromelin immunohaematology reagent IVD

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Group O Rh (D) positive reagent red blood cell IVD, antigen

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Papain immunohaematology reagent IVD

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyspecific antihuman globulin/complement IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibacterial susceptibility testing disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibacterial susceptibility testing disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antifungal susceptibility testing disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Differential/selective agar culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Differential/selective agar culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enriched broth culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-microorganism antimicrobial susceptibility culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus antibody/antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, calibrator

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad

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:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 antigen neutralization IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, calibrator

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida/yeast species culture isolate identification IVD, kit

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rabies virus envelope glycoprotein neutralizing antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acid phosphatase isoenzyme IVD, reagent

Manufacturer:

Bio-Rad Laboratories Seattle Operations Redmond

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad Laboratories Seattle Operations Redmond

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, reagent

Manufacturer:

Bio-Rad Laboratories Seattle Operations Redmond

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide coverslip IVD

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple liver disease-associated antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple liver disease-associated antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vasculitis-associated antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiplex analyser IVD, laboratory, automated

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phospholipid antibody IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG) antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Allergen-specific immunoglobulin E (IgE) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ammonia IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Full blood count IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lead IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA nucleic acid IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anaemia-related analyte IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple biogenic amine neurotransmitter IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple infectious organism/newborn TORCH screen IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple infectious organism/newborn TORCH screen IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tissue-associated protein/tumour marker IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-therapy therapeutic drug monitoring IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae nucleic acid IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, control

Manufacturer:

Bio-Rad

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:

Bio-Rad

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:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 antibody IVD, kit, immunoblot

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-AB red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-B red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C^w red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-CDE red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH005] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^b red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^a red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^b red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Kp^b red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-P1 red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS003] red blood cell grouping IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibody identification panel reagent red blood cell IVD, kit, agglutination

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antisera matrix (non-reactive) IVD, control

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monospecific anti-complement component C3 (anti-C3) IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monospecific anti-complement component C3d (anti-C3d) IVD, antibody

Manufacturer:

Bio-Rad Medical Diagnostics GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibacterial susceptibility testing disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antimicrobial activity testing agar culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antimicrobial activity testing agar culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus NS1 antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-microorganism antimicrobial susceptibility culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate washer IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple bacteria carbapenemase production IVD, kit, chromogenic

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optochin/ethylhydrocupreine differentiation disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Salmonella typhi nucleic acid IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum reagin antibody IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ABO/Rh multiple blood grouping IVD, kit, agglutination

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C^w red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Kp^a red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Lu^a red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Rh(D) standard reference solution IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS003] red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bovine serum albumin (BSA) immunohaematology reagent IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bromelin immunohaematology reagent IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell preservation/storage/dilution solution IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Column agglutination IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Column agglutination IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Group A2 Rh (D) negative reagent red blood cell IVD, antigen

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Group O Rh (D) positive reagent red blood cell IVD, antigen

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohaematology/blood bank analyser IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kidd (Jk^a & Jk^b) multiple blood grouping IVD, kit, agglutination

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate/tube/assay card incubator IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyspecific antihuman globulin/complement IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell antibody diluent IVD, reagent

Manufacturer:

DiaMed GmbH

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:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin A2 (HbA2) IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High performance liquid chromatography analyser IVD, automated

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited haemoglobinopathy IVD, kit, liquid chromatography

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vasculitis-associated antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ABO/Rh multiple blood grouping IVD, kit, agglutination

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification mastermix reagent IVD

Manufacturer:

LIfe Science Group

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

LIfe Science Group

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin A2 (HbA2) IVD, reagent

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited haemoglobinopathy IVD, kit, liquid chromatography

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin M (IgM) antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, calibrator

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vasculitis-associated antibody IVD, control

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vasculitis-associated antibody IVD, kit, multiplex

Manufacturer:

Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification mastermix kit IVD

Manufacturer:

Bio-Rad Laboratories, Inc. (DBG - Digital Biology Group)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Philadelphia chromosome/BCR-ABL transcript IVD, primer

Manufacturer:

Bio-Rad Laboratories, Inc. (DBG - Digital Biology Group)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria meningitidis culture isolate antigen IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

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

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Multiple Salmonella species culture isolate antigen IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Ham's acid red cell test IVD, reagent

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Antimicrobial susceptibility analyser IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Escherichia coli antigen IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Fungal antimicrobial susceptibility culture medium IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Vibrio cholerae antigen (multiple serotype) IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Novobiocin differentiation disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Bacitracin differentiation disc IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Multiple Plasmodium species antigen IVD, control

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Multiple Shigella species culture isolate antigen IVD, kit, agglutination

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Anti-Lu^a red blood cell grouping IVD, antibody

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Anti-A1 red blood cell grouping IVD, lectin

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Mechanical micropipette IVD

Manufacturer:

DiaMed GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis C virus total antibody IVD, kit, immunoblot

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 29, 2021

Coagulase production microbial reagent IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 29, 2021

Microplate/tube/assay card incubator IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 29, 2021

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 29, 2021

Hepatitis C virus total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 29, 2021

Microplate washer IVD

Manufacturer:

Bio-Rad

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 29, 2021

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

Last updated: December 2025