United Kingdom MHRA device registration 174159

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

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Bio-Rad ·Registered Nov 26, 2024
Registration details
Device ID
174159
MHRA Reference Number
174159
Date Registered
Nov 26, 2024
Last Updated
Apr 16, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)
Type
Class D
Manufacturer
Address
3, boulevard Raymond Poincaré
Marnes-la-Coquette, France
Created Date
Dec 29, 2021
Authorized Representative
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

Additional devices registered by the same manufacturer

Other products from same authorized representative

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

Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 189913
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 189939
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 189941
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 189935
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 189934
Glycated haemoglobin (HbA1c) IVD, reagentNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 129365
Haemoglobin A2 (HbA2) IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 129358
High performance liquid chromatography analyser IVD, automatedNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 139141
HIV1/HIV2 antigen/antibody IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD)
Device ID: 189911
Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc. (DBG - Digital Biology Group)
Device ID: 167860
About this record

Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 174159. The device is manufactured by Bio-Rad from France, 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