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Access anti-HBc IgM

Beckman Coulter, Inc. · Model D22920 · UDI-DI 15099590806323

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Facilities

Description

The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis, when used in conjunction with other serological and clinical information. The Access anti-HBc IgM assay is for use on the DxI 9000 Access Immunoassay Analyzer only. This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.