{"publicDeviceRecordKey":"05fecb95-81fb-485f-83bd-11ccb107c612","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-07-06T00:00:00.000Z","devicePublishDate":"2016-08-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"15099590209032","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Synchron","versionModelNumber":"A95550","catalogNumber":"A95550","dunsNumber":"008254708","companyName":"Beckman Coulter, Inc.","deviceCount":1,"deviceDescription":"Lactate Reagent (LACT 2 x 50)\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"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":"53072","gmdnPTName":"Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry","gmdnPTDefinition":"A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total lactate dehydrogenase (LDH) in a clinical specimen, using a spectrophotometry method.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"CFJ","productCodeName":"Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase"}]},"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":[]}}