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, Over The Counter, Test, Barbiturate, Over The Counter, Test, Benzodiazepine, Over The Counter, Test, Cannabinoid, Over The Counter, Test, Cocaine And Cocaine Metabolites, Over The Counter, Test, Methadone, Over The Counter, Test, Methamphetamine, Over The Counter, Test, Opiates, Over The Counter, Test, Phencyclidine (Pcp), Over The Counter, Test, Propoxyphene, Over The Counter, Test, Tricyclic Antidepressants, Over The Counter
Device ID00850065976594
AvailabilityOver the counter
Single useYes
MRI safetyLabeling does not contain MRI Safety Information