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 categoryEnzyme Immunoassay, Amphetamine, Enzyme Immunoassay, Barbiturate, Enzyme Immunoassay, Benzodiazepine, Enzyme Immunoassay, Cannabinoids, Enzyme Immunoassay, Cocaine And Cocaine Metabolites, Enzyme Immunoassay, Methadone, Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Phencyclidine, Radioimmunoassay, Tricyclic Antidepressant Drugs, Thin Layer Chromatography, Morphine
Device ID00850011007112
Catalog numberTNR CDOA7125A3
Single useYes
MRI safetyLabeling does not contain MRI Safety Information