CEDIA SIROLIMUS ASSAY

CEDIA SIROLIMUS ASSAY is an FDA 510(k)-cleared medical device (DEN040008) 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 July 27, 2004. Regulation: 8.