{"publicDeviceRecordKey":"06caacc5-49dc-427f-8949-89c945c535cf","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-02-11T00:00:00.000Z","devicePublishDate":"2019-01-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"03661540900037","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ELITe InGenius® PCR cassette","versionModelNumber":"INT035PCR","catalogNumber":"INT035PCR","dunsNumber":"434528644","companyName":"ELITECHGROUP SPA","deviceCount":1,"deviceDescription":"The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides consumables to be used in association with the ELITe InGenius® instrument (catalog number INT030-K) for Real Time PCR reactions. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.\nELITe InGenius® PCR Cassette is FDA cleared only for use in association with HSV1\u00262 ELITe MGB® Assay.\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":true,"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":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K180559","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"52521","gmdnPTName":"Nucleic acid extraction/isolation kit IVD","gmdnPTDefinition":"A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OOI","productCodeName":"Real Time Nucleic Acid Amplification System"}]},"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}