Device typeEthanol (ETOH) IVD, kit, rapid colorimetric, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism. It is not intended to be used for self-testing.
FDA categoryAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device ID00737051654806
Single useYes
MRI safetyLabeling does not contain MRI Safety Information