Laboratory instrument/analyser application software IVD - UK MHRA Medical Device Registration

Laboratory instrument/analyser application software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 203916. The device is manufactured by bioMerieux, Inc from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is bioMérieux 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

🇬🇧

Laboratory instrument/analyser application software IVD

MHRA Device ID: 203916•Ref: 203916

Device Type

In Vitro Diagnostic Device

Devices

Laboratory instrument/analyser application software IVD

Type

Class B

Date Registered

Nov 26, 2024

Last Updated

Apr 5, 2024

Manufacturer Information

Name

bioMerieux, Inc

Address

100 Rodolphe Street

Durham, United States

Created Date

Apr 8, 2021

Authorized Representative

Name

bioMérieux UK Ltd

Relationship Type

UK Responsible Person

Address

Chineham Gate Crockford Lane

Basingstoke, Hampshire, England, United Kingdom

Postcode: RG24 8NA

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from bioMerieux, Inc (10)

Other Products from Same Authorized Representative (10)

Laboratory instrument/analyser application software IVD - 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

Mass spectrometry analysis specimen preparation kit IVD

Blood culture analyser IVD

General-microorganism antimicrobial susceptibility culture medium IVD

Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Antimicrobial susceptibility analyser IVD

Microorganism identification/antimicrobial-susceptibility analyser IVD

Blood culture analyser IVD

Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kit

Multiple Candida/yeast species culture isolate identification IVD, kit

Antibacterial minimum inhibitory concentration (MIC) IVD

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Buffered sample diluent IVD, automated/semi-automated system

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

Clostridium difficile antigen IVD, antibody

Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)

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

D-dimer IVD, kit, enzyme immunoassay (EIA)

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