CEDIA DAU 6-ACETYLMORPHINE ASSAY

CEDIA DAU 6-ACETYLMORPHINE ASSAY is an FDA 510(k)-cleared medical device (K001178) manufactured by Microgenics Corp.. 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 June 8, 2000. Regulation: 8.