Manufacturer's Devices - Abbott Diagnostics Korea Inc.

Address:




65

Borahagal-Ro Giheung-Gu

Gyeonggi-Do

Yongin-Si 17099

South Korea


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
Hepatitis C virus total antibody IVD kit rapid ICT clinicalHepatitis C virus total 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
HIV1/HIV2/Treponema pallidum antibody IVD kit rapid ICT clinicalHIV1/HIV2/Treponema pallidum antibody IVD kit rapid ICT clinicalIVD Annex II List A
Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Dengue virus antigen IVD kit rapid ICT clinicalDengue virus antigen IVD kit rapid ICT clinicalIVD General
Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalDengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
Plasmodium falciparum antigen IVD kit immunochromatographic test (ICT)Plasmodium falciparum antigen IVD kit immunochromatographic test (ICT)IVD General
Rotavirus antigen IVD kit rapid ICT clinicalRotavirus antigen IVD kit rapid ICT clinicalIVD General
Vibrio cholerae antigen (multiple serotype) IVD kit rapid ICT clinicalVibrio cholerae antigen (multiple serotype) IVD kit rapid ICT clinicalIVD General
Treponema pallidum total antibody IVD kit rapid ICT clinicalTreponema pallidum total antibody IVD kit rapid ICT clinicalIVD General
Multiple Leptospira species immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)Multiple Leptospira species immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA)IVD General
Adenovirus antigen IVD kit rapid ICT clinicalAdenovirus antigen IVD kit rapid ICT clinicalIVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Norovirus antigen IVD kit rapid ICT clinicalNorovirus antigen IVD kit rapid ICT clinicalIVD General
Helicobacter pylori antigen IVD kit rapid ICT clinicalHelicobacter pylori antigen IVD kit rapid ICT clinicalIVD General
Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinicalTrypanosoma cruzi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinicalIVD General