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 - Abbott Rapid Diagnostics Jena GmbH

Address:

Orlaweg 1

Jena

Thuringia 07743

Germany

Authorised Representative/ UK Responsible Person
Name: Unipath Limited (trading as Alere International)
Address:

Clearblue Innovation Centre Priory Business Park

Stannard Way

Bedford

Bedfordshire MK44 3UP

England United Kingdom

Code/Term Type

SARS-CoV-2 antigen IVD kit rapid ICT clinical SARS-CoV-2 antigen IVD kit rapid ICT clinical IVD Devices for Self-Testing

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical IVD General

Clinical laboratory analyser/instrument control unit IVD Clinical laboratory analyser/instrument control unit IVD IVD General

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

CD4 cell marker IVD kit fluorescent immunoassay rapid CD4 cell marker IVD kit fluorescent immunoassay rapid IVD General

SARS-CoV-2 antigen IVD control SARS-CoV-2 antigen IVD control IVD General

SARS-CoV-2 antigen IVD kit rapid ICT clinical SARS-CoV-2 antigen IVD kit rapid ICT clinical 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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Code/Term		Type
SARS-CoV-2 antigen IVD kit rapid ICT clinical	SARS-CoV-2 antigen IVD kit rapid ICT clinical	IVD Devices for Self-Testing
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical	SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical	IVD General
Clinical laboratory analyser/instrument control unit IVD	Clinical laboratory analyser/instrument control unit IVD	IVD General
Optical instrument performance standard calibrator/control IVD reusable	Optical instrument performance standard calibrator/control IVD reusable	IVD General
CD4 cell marker IVD kit fluorescent immunoassay rapid	CD4 cell marker IVD kit fluorescent immunoassay rapid	IVD General
SARS-CoV-2 antigen IVD control	SARS-CoV-2 antigen IVD control	IVD General
SARS-CoV-2 antigen IVD kit rapid ICT clinical	SARS-CoV-2 antigen IVD kit rapid ICT clinical	IVD General