Device Dossier

Elecsys Anti-HBs II (cobas e 402/801) - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for Elecsys Anti-HBs II (cobas e 402/801) - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay (Hepatitis B…

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 for use on the cobas e immunoassay analyzers for the in vitro quantitative determination of human antibodies to the hepatitis B surface antigen (HBsAg).

TGA Public Summary