{"publicDeviceRecordKey":"8a1e3ec9-3faa-4f36-9018-a93bade35bc0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-10-09T00:00:00.000Z","devicePublishDate":"2023-10-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03661540304286","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Direct A1c Control Kit","versionModelNumber":"55136","catalogNumber":"55136","dunsNumber":"052423787","companyName":"ELITECHGROUP INC.","deviceCount":1,"deviceDescription":"A material which is used to verify the performance of Direct A1c Reagent Kit 55370.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"(800) 453 2725","phoneExtension":null,"email":"service.ebs@elitechgroup.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K031539","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44435","gmdnPTName":"Glycated haemoglobin (HbA1c) IVD, control","gmdnPTDefinition":"A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LCP","productCodeName":"Assay, Glycosylated Hemoglobin"}]},"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}