Device Dossier

Elecsys Anti-HBc II (300 tests) - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for Elecsys Anti-HBc II (300 tests) - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay (Hepatitis B virus core…

Intended purpose

Immunoassay for the in vitro qualitative determination of IgG and IgM antibodies to the Hepatitis B core antigen in human serum and plasma, for diagnostic use and for screening of blood donations

Functional description

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

TGA Public Summary