Device typeAmphetamine-specific IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of a specific amphetamine 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.
FDA categoryTest, Amphetamine, Employment And Insurance Testing, Exempt, Test, Barbiturate, Employment And Insurance Testing, Exempt, Test, Cannabinoid, Employment And Insurance Testing, Exempt, Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt, Test, Methadone, Employment And Insurance Testing, Exempt, Test, Methamphetamine, Employment And Insurance Testing, Exempt, Test, Opiates, Employment And Insurance Testing, Exempt
Device ID00850054867117
Single useYes
MRI safetyLabeling does not contain MRI Safety Information