Manufacturer's By Device HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid-HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Korea Inc.65
Borahagal-Ro Giheung-Gu
Gyeonggi-Do
Yongin-Si 17099

South Korea
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
03/30/202113027
Abbott Diagnostics Medical Co. Ltd.357 Matsuhidai Matsudo-shi

Chiba
270-2214

Japan
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
04/19/202113507
Atomo Diagnostics LimitedLevel 2 701-703 Parramatta Road

Leichhardt
NSW 2040

Australia
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
04/15/202113431
bioLytical Laboratories Inc.406-13251 Delf Place

Richmond
British Columbia V6V 2A2

Canada
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
04/21/202113307
MP Biomedicals Asia Pacific Pte Ltd2 Pioneer Place

Singapore
627885

Singapore
Mornington 2000 LLP trading as Sterilab Services18 Mornington Terrace

Harrogate
North Yorkshire HG1 5DH

England United Kingdom
09/27/202117853
Orasure Technologies Inc.220 East First Street

Bethlehem
Pennsylvania 18015-1360

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
05/04/202114387