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 - Quotient Suisse SA

Address:

Route de Crassier 13

Eysins

Vaud 1262

Switzerland

Authorised Representative/ UK Responsible Person
Name: Alba Bioscience Limited
Address:

James Hamilton Way

Penicuik

EH26 0BF

Scotland United Kingdom

Code/Term Type

Multiple blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD kit microarray Multiple blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD kit microarray IVD Annex II List B

Multiple blood group system IVD kit microarray Multiple blood group system IVD kit microarray IVD Annex II List A

Multiple immunohaematology test IVD control Multiple immunohaematology test IVD control IVD Annex II List A

Multiple blood group system/blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD reagent Multiple blood group system/blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD reagent IVD General

Donor blood/tissue testing analyser IVD Donor blood/tissue testing 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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Code/Term		Type
Multiple blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD kit microarray	Multiple blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD kit microarray	IVD Annex II List B
Multiple blood group system IVD kit microarray	Multiple blood group system IVD kit microarray	IVD Annex II List A
Multiple immunohaematology test IVD control	Multiple immunohaematology test IVD control	IVD Annex II List A
Multiple blood group system/blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD reagent	Multiple blood group system/blood-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD reagent	IVD General
Donor blood/tissue testing analyser IVD	Donor blood/tissue testing analyser IVD	IVD General