{"publicDeviceRecordKey":"9a202e1b-e7ee-471c-813a-1407469492f3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2023-06-29T00:00:00.000Z","devicePublishDate":"2016-09-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"30014613330516","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"D3","versionModelNumber":"DFA Metapneumovirus Kit","catalogNumber":"01-030000","dunsNumber":"117359612","companyName":"DIAGNOSTIC HYBRIDS, INC.","deviceCount":1,"deviceDescription":"MPV DFA KIT","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(858)552-1100","phoneExtension":null,"email":"technicalsupport@quidel.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62583","gmdnPTName":"Human metapneumovirus (hMPV) antigen IVD, kit, fluorescent immunoassay","gmdnPTDefinition":"A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from human metapneumovirus (hMPV) in a clinical specimen, using a fluorescent immunoassay method.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OMG","productCodeName":"Antisera, fluorescent, human metapneumovirus"}]},"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":[]}}