{"publicDeviceRecordKey":"0af5c6bf-7c27-4293-b88c-f53a9ddaf4db","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-03-26T00:00:00.000Z","devicePublishDate":"2025-03-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B502BSB9289CS0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MUC4 Control Slides","versionModelNumber":"BSB-9289-CS","catalogNumber":"BSB-9289-CS","dunsNumber":"102855447","companyName":"BIO SB, INC.","deviceCount":1,"deviceDescription":"MUC4 Control Slides","DMExempt":false,"premarketExempt":true,"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":"+1(800)561-1145","phoneExtension":null,"email":"sales@biosb.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"53946","gmdnPTName":"Mucin IVD, control","gmdnPTDefinition":"A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of mucin protein in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LJG","productCodeName":"QUALITY CONTROL SLIDES"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"25"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"20"},"storageHandlingSpecialConditionText":null}]},"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":[]}}