{"publicDeviceRecordKey":"67a5bf7a-c6b9-4029-a687-ea723cb1ec9b","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-05-12T00:00:00.000Z","devicePublishDate":"2026-05-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"15099590806323","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Access anti-HBc IgM  ","versionModelNumber":"D22920","catalogNumber":"D22920","dunsNumber":"008254708","companyName":"Beckman Coulter, Inc.","deviceCount":1,"deviceDescription":"The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative\ndetection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human pediatric (3 through 21 years) and\nadult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2)\nEDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] using\nthe DxI 9000 Access Immunoassay Analyzer.\nThe Access anti-HBc IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis B\nvirus (HBV) infection in individuals with signs and symptoms of hepatitis, when used in conjunction with other serological\nand clinical information.\nThe Access anti-HBc IgM 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":"48298","gmdnPTName":"Hepatitis B virus core immunoglobulin M (IgM) 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 immunoglobulin M (IgM) 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":[]}}