67a5bf7a-c6b9-4029-a687-ea723cb1ec9bNewPublished12026-05-122026-05-04In Commercial Distribution15099590806323PrimaryGS1Access anti-HBc IgM D22920D22920008254708Beckman Coulter, Inc.1The 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.falsefalsefalsetruefalsefalsetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse48298Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.falseActiveSEIQualitative And Quantitative Hepatitis B Virus Antibody Assaysfalsefalse