Device Category Dossier

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Device Category Dossier for Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay. Australian ARTG records,…

Anti-HBc

IgM immunoassays are chemiluminescent or microparticle-based immunoassays that detect IgM antibodies to hepatitis B virus core antigen in human serum and plasma. These assays aid in the diagnosis of acute or recent hepatitis B virus infection , and can be used in combination with other hepatitis B virus marker assays to define the clinical status of infected patients or combined with other viral hepatitis assays for diagnosis of patients presenting symptoms of acute viral hepatitis.