{"publicDeviceRecordKey":"37386602-ee52-4d1b-b40e-37c5cd7955e9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-12-10T00:00:00.000Z","devicePublishDate":"2018-06-22T00:00:00.000Z","deviceCommDistributionEndDate":"2019-01-10T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B085K080M60","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Audit MicroControls Control LQ Vitamin D for Roche Systems","versionModelNumber":"K080M-6","catalogNumber":null,"dunsNumber":"077974989","companyName":"AALTO SCIENTIFIC","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41252","gmdnPTName":"25-Hydroxy vitamin D3 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 25-hydroxy vitamin D3 in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[]},"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":[]}}