{"publicDeviceRecordKey":"2e57dda3-b80a-4fd9-b7c8-c27cffc54cc3","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":"03661540300035","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Microsed-System® Automated ESR Analyzer","versionModelNumber":"PRD-MSS-EL-08TKNE","catalogNumber":"PRD-MSS-EL-08TKNE","dunsNumber":"052423787","companyName":"ELITECHGROUP INC.","deviceCount":1,"deviceDescription":"The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"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"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"56691","gmdnPTName":"Erthrocyte sedimentation rate (ESR) analyser IVD","gmdnPTDefinition":"An electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GKB","productCodeName":"Device, Automated Sedimentation Rate"}]},"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":[]}}