Device Dossier

ARCHITECT Anti-HBc IgM (6C33) - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for ARCHITECT Anti-HBc IgM (6C33) - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay…

Intended purpose

A chemiluminescent microparticle immunoassay for the qualitative determination of anti-HBc in clinical specimens

Functional description

A chemiluminescent microparticle immunoassay for the qualitative determination of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma as an aid in the diagnosis of acute or recent hepatitis B viral infection.

TGA Public Summary