Manufacturer's Devices - Abbott Diagnostics Medical Co. Ltd.

Address:




357 Matsuhidai Matsudo-shi



Chiba

270-2214

Japan


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
HIV1/HIV2 antigen/antibody IVD kit rapid ICT clinicalHIV1/HIV2 antigen/antibody IVD kit rapid ICT clinicalIVD Annex II List A
HIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testHIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-testIVD Annex II List A
Hepatitis B virus surface antigen IVD kit rapid ICT clinicalHepatitis B virus surface antigen IVD kit rapid ICT clinicalIVD Annex II List A
HIV1/HIV2 antigen/antibody IVD controlHIV1/HIV2 antigen/antibody IVD controlIVD Annex II List A
Treponema pallidum total antibody IVD kit rapid ICT clinicalTreponema pallidum total antibody IVD kit rapid ICT clinicalIVD General
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Capillary blood collection tube IVD K2EDTACapillary blood collection tube IVD K2EDTAIVD General
Buffered isotonic saline reagent IVDBuffered isotonic saline reagent IVDIVD General