ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)

ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) is an FDA 510(k)-cleared medical device (K952096) manufactured by Tcpi, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 1995. Regulation: 8.