Device Category Dossier

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

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

Anti-hepatitis

B core antibody immunoassay devices are paramagnetic particle chemiluminescent immunoassays that qualitatively detect total antibodies against the hepatitis B virus core antigen in human serum and plasma. These assays are used as an aid in diagnosing hepatitis B virus infection and as screening tests for blood and plasma donors.