Otc test sample collection systems for drugs of abuse testing

In this classification, (OTC) Over-the-counter test sample collection systems for drugs of abuse testing are restricted devices used for sample testing that shall be performed in a laboratory using screening tests that have been approved, cleared, or otherwise recognized by the Food and Drug Administration as accurate and reliable for the testing of such specimens for identifying drugs of abuse or their metabolites US FDA regulates Otc test sample collection systems for drugs of abuse testing under 21 CFR 864.3260 and under FDA product code MPQ.