{"publicDeviceRecordKey":"5d4ca723-2034-41a4-a4ad-25bdbe8ac647","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-04-03T00:00:00.000Z","devicePublishDate":"2019-03-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B07603100","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Fentanyl  Enzyme Immunoassay","versionModelNumber":"0310","catalogNumber":"0310","dunsNumber":"840839190","companyName":"LIN-ZHI INTERNATIONAL, INC.","deviceCount":1,"deviceDescription":"Small Test Kit.\nAntibody/Substrate Reagent (R1): 100 mL.\nEnzyme Conjugate Reagent (R2): 37.5 mL.\n","DMExempt":false,"premarketExempt":false,"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":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K181159","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63018","gmdnPTName":"Fentanyl IVD, kit, enzyme immunoassay (EIA)","gmdnPTDefinition":"A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen, using an enzyme immunoassay (EIA) method.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DJG","productCodeName":"Enzyme Immunoassay, Opiates"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"8"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"2"},"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}