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 - OraSure Technologies Inc.

Address:

220 E. 1st Street

Bethlehem

18015

United States

Authorised Representative/ UK Responsible Person
Name: Qarad UK Ltd.
Address:

8 Northumberland Ave

Westminster

London WC2N 5BY

England United Kingdom

Code/Term Type

Hepatitis C virus antibody/antigen IVD control Hepatitis C virus antibody/antigen IVD control IVD Annex II List A

Hepatitis C virus total antibody IVD kit rapid ICT clinical Hepatitis C virus total antibody IVD kit rapid ICT clinical IVD Annex II List A

Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Class I

Oral/upper respiratory tract specimen collection kit IVD clinical Oral/upper respiratory tract specimen collection kit IVD clinical IVD General

HIV1/HIV2 antibody IVD control HIV1/HIV2 antibody IVD control IVD Annex II List A

HIV1/HIV2 antibody IVD kit rapid ICT self-testing HIV1/HIV2 antibody IVD kit rapid ICT self-testing IVD Annex II List A

HIV1/HIV2 antibody IVD kit rapid ICT clinical HIV1/HIV2 antibody IVD kit rapid ICT clinical IVD Annex II List A

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
Hepatitis C virus antibody/antigen IVD control	Hepatitis C virus antibody/antigen IVD control	IVD Annex II List A
Hepatitis C virus total antibody IVD kit rapid ICT clinical	Hepatitis C virus total antibody IVD kit rapid ICT clinical	IVD Annex II List A
Oral/upper respiratory tract specimen collection kit	Oral/upper respiratory tract specimen collection kit	Class I
Oral/upper respiratory tract specimen collection kit IVD clinical	Oral/upper respiratory tract specimen collection kit IVD clinical	IVD General
HIV1/HIV2 antibody IVD control	HIV1/HIV2 antibody IVD control	IVD Annex II List A
HIV1/HIV2 antibody IVD kit rapid ICT self-testing	HIV1/HIV2 antibody IVD kit rapid ICT self-testing	IVD Annex II List A
HIV1/HIV2 antibody IVD kit rapid ICT clinical	HIV1/HIV2 antibody IVD kit rapid ICT clinical	IVD Annex II List A