Device Dossier

Elecsys Anti-HCV II (cobas e 402/801) – Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Device Dossier for Elecsys Anti-HCV II (cobas e 402/801) – Hepatitis C virus total antibody IVD, kit, chemiluminescent assay (Hepatitis C virus total…

Intended purpose

Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma, for diagnostic use and screening of blood donations.

Functional description

An electrochemiluminescence immunoassay “ECLIA” intended for use on the cobas e immunoassay analyzers for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV).

TGA Public Summary