{"publicDeviceRecordKey":"9dcd5f18-e101-4b80-8088-5e8c5ab0e257","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":"15099590806330","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Access anti-HBc IgM Calibrator","versionModelNumber":"D22921","catalogNumber":"D22921","dunsNumber":"008254708","companyName":"Beckman Coulter, Inc.","deviceCount":1,"deviceDescription":"The Access anti-HBc IgM Calibrator is intended to calibrate the Access anti-HBc IgM assay for the in vitro qualitative\ndetection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human serum and plasma using the DxI\n9000 Access Immunoassay Analyzer.","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":"41981","gmdnPTName":"Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator","gmdnPTDefinition":"A material which is used to establish known points of reference for an assay 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.","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":[]}}