Device Dossier
Elecsys HBsAg II (cobas e 402/801) - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Device Dossier for Elecsys HBsAg II (cobas e 402/801) - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay (Hepatitis B virus…
Intended purpose
Immunoassay for the in vitro qualitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma, for diagnostic use and screening of blood donations.
Functional description
An electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers for the in vitro qualitative determination of hepatitis B surface antigen (HBsAg).