{"publicDeviceRecordKey":"1bcac047-cba0-4bbc-830f-19758074799b","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-04-07T00:00:00.000Z","devicePublishDate":"2026-03-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"15099590806293","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Hepatitis B Virus core Total Antibody","versionModelNumber":"D22917","catalogNumber":"D22917","dunsNumber":"008254708","companyName":"Beckman Coulter, Inc.","deviceCount":1,"deviceDescription":"The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative\ndetection of total antibodies to hepatitis B virus core antigen (anti-HBc) in human pediatric (2 through 21 years) and adult\nserum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA,\ntripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD) and citrate phosphate dextrose (CPD)] using the\nDxI 9000 Access Immunoassay Analyzer.\nThe Access anti-HBc Total assay may be used as an aid in the laboratory diagnosis of acute, chronic or resolved hepatitis\nB virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, including\npregnant women, when used in conjunction with other laboratory results and clinical information.\nThe Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only.\nThis assay is not intended for the screening of blood, plasma, and cell or tissue donors.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"48304","gmdnPTName":"Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay","gmdnPTDefinition":"A 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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"SEI","productCodeName":"Qualitative And Quantitative Hepatitis B Virus Antibody Assays"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}