Device Dossier

Access HBc Ab assay - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for Access HBc Ab assay - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay (Hepatitis B virus core total…

Intended purpose

The Access HBc Ab assay is a qualitative immunoassay integrated to the Access Immunoassay Systems, for the detection of antibodies directed against hepatitis B core antigen in human serum or plasma.

Functional description

Qualitative immunoassay integrated to the Access Immunoassay Systems, for the detection of antibodies directed against hepatitis B core antigen in human serum or plasma

TGA Public Summary