Device Category Dossier

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Device Category Dossier for Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay. Australian ARTG records, sponsors, device…

Anti-hepatitis

B surface antibody (anti-HBs) immunoassays are in vitro diagnostic tests that use chemiluminescent or immunoassay methodologies to quantitatively or qualitatively determine total antibodies to hepatitis B surface antigen in human serum or plasma. These assays aid in the laboratory diagnosis of hepatitis B virus infection when used with other serological and clinical information, and assist in determining susceptibility to hepatitis B virus infection in individuals prior to or following hepatitis B vaccination or when vaccination status is unknown.