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 clinical | HIV1/HIV2 antigen/antibody IVD kit rapid ICT clinical | IVD Annex II List A
|
| HIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-test | HIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-test | IVD Annex II List A
|
| Hepatitis B virus surface antigen IVD kit rapid ICT clinical | Hepatitis B virus surface antigen IVD kit rapid ICT clinical | IVD Annex II List A
|
| HIV1/HIV2 antigen/antibody IVD control | HIV1/HIV2 antigen/antibody IVD control | IVD Annex II List A
|
| Treponema pallidum total antibody IVD kit rapid ICT clinical | Treponema pallidum total antibody IVD kit rapid ICT clinical | IVD General
|
| Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid | Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid | IVD General
|
| Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical | Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical | IVD General
|
| Capillary blood collection tube IVD K2EDTA | Capillary blood collection tube IVD K2EDTA | IVD General
|
| Buffered isotonic saline reagent IVD | Buffered isotonic saline reagent IVD | IVD General
|
| Buffered isotonic saline reagent IVD | Buffered isotonic saline reagent IVD | Class A
|
| Buffered isotonic saline reagent IVD | Buffered isotonic saline reagent IVD | Class A
|