{"publicDeviceRecordKey":"d746974b-8b7d-4165-bb2e-247518de49c5","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-11-28T00:00:00.000Z","devicePublishDate":"2022-10-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00856464008409","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DrugConfirm","versionModelNumber":"CB-DC-4PanelOTC","catalogNumber":null,"dunsNumber":"806524968","companyName":"CONFIRM BIOSCIENCES, INC.","deviceCount":1,"deviceDescription":"4 Drugs Tested Home Drug Test","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":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"55570","gmdnPTName":"Cocaine/cocaine metabolite IVD, reagent","gmdnPTDefinition":"A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"55501","gmdnPTName":"Methamphetamine-specific IVD, reagent","gmdnPTDefinition":"A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of a specific methamphetamine in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"55724","gmdnPTName":"Opiate/opiate metabolite IVD, reagent","gmdnPTDefinition":"A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"55553","gmdnPTName":"Cannabinoid/cannabinoid metabolite IVD, reagent","gmdnPTDefinition":"A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NFY","productCodeName":"Test, Cocaine And Cocaine Metabolites, Over The Counter"},{"productCode":"NGG","productCodeName":"Test, Methamphetamine, Over The Counter"},{"productCode":"NGL","productCodeName":"Test, Opiates, Over The Counter"},{"productCode":"NFW","productCodeName":"Test, Cannabinoid, Over The Counter"}]},"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":[]}}