STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)

STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) is an FDA 510(k)-cleared medical device (K981341) manufactured by OraSure Technologies, 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 May 21, 1998. Regulation: 8.