MGC HEALTH

Device typeCocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Device ID00383173000269

Single useYes

MRI safetyLabeling does not contain MRI Safety Information