ACCESS anti-HBc IgM - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc IgM assay is intended to be used as an aid in the diagnosis of acute or recent hepatitis B virus (HBV) infection. The Access anti-HBc IgM assay is for use on the DxI 9000 Access Immunoassay Analyzer only.

Functional description

The Access anti-HBc IgM assay is intended aid in the detection of IgM antibodies to hepatitis B virus (anti-HBc IgM).