Device Dossier

Elecsys Anti-HBs II (cobas e 411/601/602) - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for Elecsys Anti-HBs II (cobas e 411/601/602) - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay (Hepatitis…

Intended purpose

Immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma, for diagnostic use and testing of blood donations.

Functional description

An electrochemiluminescence immunoassay "ECLIA" intended for use on the cobas e immunoassay analyzers.

TGA Public Summary