{"publicDeviceRecordKey":"f131d667-e1d9-422f-b0b5-852cbaead32b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2022-06-10T00:00:00.000Z","devicePublishDate":"2016-09-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00817405020249","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Alere iCup Dx","versionModelNumber":"I-DXA-1107-142","catalogNumber":"I-DXA-1107-142","dunsNumber":"019410187","companyName":"Instant Technologies, Inc.","deviceCount":1,"deviceDescription":"Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+COC+MTD+THC with adulteration tests Cr, Ni,pH, Bl, S.G., CLIA Waived","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":"1-800-340-4029","phoneExtension":null,"email":"Qa.Portsmouth@abbott.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K052115","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46994","gmdnPTName":"Multiple drugs of abuse IVD, kit, rapid ICT, clinical","gmdnPTDefinition":"A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DIS","productCodeName":"Enzyme Immunoassay, Barbiturate"},{"productCode":"JXM","productCodeName":"Enzyme Immunoassay, Benzodiazepine"},{"productCode":"DIO","productCodeName":"Enzyme Immunoassay, Cocaine And Cocaine Metabolites"},{"productCode":"LDJ","productCodeName":"Enzyme Immunoassay, Cannabinoids"},{"productCode":"DJC","productCodeName":"Thin Layer Chromatography, Methamphetamine"},{"productCode":"DJG","productCodeName":"Enzyme Immunoassay, Opiates"},{"productCode":"DKZ","productCodeName":"Enzyme Immunoassay, Amphetamine"},{"productCode":"DJR","productCodeName":"Enzyme Immunoassay, Methadone"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"2"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"86"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"36"},"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}