COMA COCAINE METABOLITE ASSAY (EIA)

COMA COCAINE METABOLITE ASSAY (EIA) is an FDA 510(k)-cleared medical device (K895043) manufactured by Serex, 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 November 7, 1989. Regulation: 8.