1bcac047-cba0-4bbc-830f-19758074799bNewPublished12026-04-072026-03-30In Commercial Distribution15099590806293PrimaryGS1Hepatitis B Virus core Total AntibodyD22917D22917008254708Beckman Coulter, Inc.1The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies to hepatitis B virus core antigen (anti-HBc) in human pediatric (2 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 Total assay may be used as an aid in the laboratory diagnosis of acute, chronic or resolved hepatitis B virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, including pregnant women, when used in conjunction with other laboratory results and clinical information. The Access anti-HBc Total 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 Informationtruefalse48304Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total 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