QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)

QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) is an FDA 510(k)-cleared medical device (K972619) manufactured by Phamatech. 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 19, 1997. Regulation: 8.