United Kingdom MHRA device registration 189929

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

United Kingdom·In Vitro Diagnostic Device·Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)·Registered Nov 26, 2024

Registration details

Device ID: 189929
MHRA Reference Number: 189929
Date Registered: Nov 26, 2024
Last Updated: Apr 16, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Type: Class C

Manufacturer

Name: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Address: 4000 Alfred Nobel Drive
Hercules, United States
Created Date: Dec 29, 2021

Authorized Representative

Name: BIO-RAD LABORATORIES LIMITED
Relationship Type: UK Responsible Person
Address: The Junction 3rd And 4th Floor, Station Road, Watford, United Kingdom, WD17 1ET
WATFORD, Hertfordshire, England, United Kingdom
Postcode: wd17 1et

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

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

Additional devices registered by the same manufacturer

Nucleic acid amplification mastermix kit IVDMar 29, 2025

Type: In Vitro Diagnostic Device

Device ID: 214378

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayFeb 14, 2025

Type: In Vitro Diagnostic Device

Device ID: 210835

Native DNA antibody (anti-nDNA) IVD, reagentFeb 14, 2025

Type: In Vitro Diagnostic Device

Device ID: 210834

High performance liquid chromatography analyser IVDJan 31, 2025

Type: In Vitro Diagnostic Device

Device ID: 209869

Glycated haemoglobin (HbA1C) analyser IVDJan 29, 2025

Type: In Vitro Diagnostic Device

Device ID: 209703

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatographyJan 29, 2025

Type: In Vitro Diagnostic Device

Device ID: 209704

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatographyNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 129364

Glycated haemoglobin (HbA1c) IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 129356

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 189936

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 189926

Other products from same authorized representative

Additional devices represented by BIO-RAD LABORATORIES LIMITED in the UK

Inherited haemoglobinopathy IVD, kit, liquid chromatographyNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 129363

Multiple Coeliac disease-associated antibody IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 189916

Haemoglobin A2 (HbA2) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 129357

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 189927

Measles virus immunoglobulin M (IgM) antibody IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 189948

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplexNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 189915

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 189940

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 189938

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 189933

Multiple drugs of abuse IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

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

Device ID: 129359

About this record

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 189929. The device is manufactured by Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD) from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is BIO-RAD LABORATORIES LIMITED.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device