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 - ChemBio Diagnostic System Inc

Address:

555 Wireless Boulevard Hauppauge

New York

11788

United States

Authorised Representative/ UK Responsible Person
Name: Luas Diagnostics
Address:

40 Occam Road

Guildford

Surrey GU2 7YG

England United Kingdom

Code/Term Type

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

HIV1/HIV2 antibody IVD kit rapid ICT self-testing HIV1/HIV2 antibody IVD kit rapid ICT self-testing Conformity Assessment Certificate Expired IVD General

HIV1/HIV2 antibody IVD kit rapid ICT self-testing HIV1/HIV2 antibody IVD kit rapid ICT self-testing Conformity Assessment Certificate Expired 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
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
HIV1/HIV2 antibody IVD kit rapid ICT self-testing	HIV1/HIV2 antibody IVD kit rapid ICT self-testing Conformity Assessment Certificate Expired	IVD General
HIV1/HIV2 antibody IVD kit rapid ICT self-testing	HIV1/HIV2 antibody IVD kit rapid ICT self-testing Conformity Assessment Certificate Expired	IVD Annex II List A