Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 192583. The device is manufactured by Beckman Coulter Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Beckman Coulter UK Ltd.

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

🇬🇧

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

MHRA Device ID: 192583•Ref: 192583

Device Type

In Vitro Diagnostic Device

Devices

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Type

Class D

Date Registered

Nov 26, 2024

Last Updated

Aug 29, 2024

Manufacturer Information

Name

Beckman Coulter Inc.

Address

250 South Kraemer Boulevard

Brea, California, United States

Created Date

Apr 29, 2021

Authorized Representative

Name

Beckman Coulter UK Ltd

Relationship Type

UK Responsible Person

Address

Oakley Court Kingsmead Busines sPark London Rd

High Wycombe, Bucks, United Kingdom

Postcode: HP11 1JU

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Beckman Coulter Inc. (10)

Other Products from Same Authorized Representative (10)

Hepatitis B virus surface antigen 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

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

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

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

Clostridium difficile antigen IVD, antibody

Interleukin-6 (IL-6) IVD, kit, rapid ICT, clinical

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

Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Legionella pneumophila antigen IVD, kit, rapid ICT, clinical

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Hepatitis B virus surface total antibody IVD, calibrator

Hepatitis B virus surface total antibody IVD, control

Creatinine IVD, kit, spectrophotometry

Complement components C4/C4c IVD, kit, nephelometry/turbidimetry

Complement factor B IVD, reagent

Chromogen indicator IVD, kit, spectrophotometry

Cannabinoid/cannabinoid metabolite IVD, calibrator

Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Lipoprotein A IVD, calibrator

CD10 cell marker IVD, antibody

CD117 (c-kit) cell marker IVD, antibody

CD11b cell marker IVD, antibody

CD14 cell marker IVD, antibody

CD19 cell marker IVD, antibody

CD1a cell marker IVD, antibody

CD20 cell marker IVD, antibody

CD23 cell marker IVD, antibody

CD3 cell marker IVD, antibody

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)