Device typeTricyclic antidepressant 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 tricyclic antidepressant drugs 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 categoryHIGH PRESSURE LIQUID CHROMATOGRAPHY, TRICYCLIC ANTIDEPRESSANT DRUGS, RADIOIMMUNOASSAY, TRICYCLIC ANTIDEPRESSANT DRUGS, U.V. SPECTROMETRY, TRICYCLIC ANTIDEPRESSANT DRUGS
Device ID00842768001277
Catalog number6A119UL
Single useYes
MRI safetyLabeling does not contain MRI Safety Information