CEDIA Heroin Metabolite (6-AM) Assay

CEDIA Heroin Metabolite (6-AM) Assay is an FDA 510(k)-cleared medical device (K173183) manufactured by Microgenics Corporation. 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 21, 2017. Regulation: 8.