HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 189910. 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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

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

MHRA Device ID: 189910•Ref: 189910

Device Type

In Vitro Diagnostic Device

Devices

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

Type

Class D

Date Registered

Nov 26, 2024

Last Updated

Apr 16, 2024

Manufacturer Information

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

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Bio-Rad Laboratories, Inc., Clinical Systems Division (CSD) (10)

Other Products from Same Authorized Representative (10)

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

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

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

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

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

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Nucleic acid amplification mastermix kit IVD

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

Native DNA antibody (anti-nDNA) IVD, reagent

High performance liquid chromatography analyser IVD

Glycated haemoglobin (HbA1C) analyser IVD

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

Glycated haemoglobin (HbA1c) IVD, calibrator

Glycated haemoglobin (HbA1C) analyser IVD

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

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

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

Bovine serum albumin (BSA) immunohaematology reagent IVD

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

Anti-Rh(D) standard reference solution IVD

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

SARS-CoV-2 nucleic acid IVD, control

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

ABO/Rh multiple blood grouping IVD, kit, agglutination

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

Bromelin immunohaematology reagent IVD