{"publicDeviceRecordKey":"6e50f674-7ed2-45f5-9fc6-ec6e6079ed61","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-10-02T00:00:00.000Z","devicePublishDate":"2020-09-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00811727017444","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Pointe Oxycodone Reagent Set","versionModelNumber":"60-OX0480-100","catalogNumber":"60-OX0480-100","dunsNumber":"052845583","companyName":"HORIBA INSTRUMENTS INCORPORATED","deviceCount":1,"deviceDescription":"Pointe Oxycodone Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Oxycodone Reagent Set is intended for the qualitative and semi-quantitative determination of oxycodone in human urine, at cutoff values of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.\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":[{"phone":"800-445-9853","phoneExtension":null,"email":"techservice@medtestdx.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K120763","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62306","gmdnPTName":"Oxycodone 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 oxycodone 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}