Elecsys Anti-HBc IgM (cobas e 402/801) - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

Immunoassay for the in vitro qualitative determination of IgM antibodies to the hepatitis B core antigen in human serum and plasma, for diagnostic use and testing of blood donations.

Functional description

An electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers for the in vitro qualitative determination of IgM antibodies to the hepatitis B core antigen.