Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - bioMerieux Inc

Address:

100 Rodolphe Street

Durham

NC 27712

United States

Authorised Representative/ UK Responsible Person
Name: bioMérieux UK Ltd
Address:

Chineham Gate Crockford Lane

Basingstoke

Hampshire RG24 8NA

England United Kingdom

Code/Term Type

Multiple anaerobic bacteria species culture isolate identification IVD kit Multiple anaerobic bacteria species culture isolate identification IVD kit IVD General

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

Multiple gram negative bacteria species culture isolate identification IVD kit Multiple gram negative bacteria species culture isolate identification IVD kit IVD General

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

Optical laboratory instrument performance standard calibrator/control IVD reusable Optical laboratory instrument performance standard calibrator/control IVD reusable IVD General

Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD IVD General

Saline suspension medium/diluent IVD Saline suspension medium/diluent IVD IVD General

Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD IVD General

Multiple Candida/yeast species culture isolate identification IVD kit Multiple Candida/yeast species culture isolate identification IVD kit IVD General

Microbial identification mass spectrometry system IVD Microbial identification mass spectrometry system IVD IVD General

General-microorganism antimicrobial susceptibility culture medium IVD General-microorganism antimicrobial susceptibility culture medium IVD IVD General

Microorganism identification/antimicrobial-susceptibility analyser IVD semi-automated Microorganism identification/antimicrobial-susceptibility analyser IVD semi-automated IVD General

Blood culture analyser IVD Blood culture analyser IVD IVD General

Blood culture analyser IVD Blood culture analyser IVD IVD General

Blood culture analyser IVD Blood culture analyser IVD IVD General

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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