CEDIA VANCOMYCIN ASSAY

CEDIA VANCOMYCIN ASSAY is an FDA 510(k)-cleared medical device (K032811) 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 November 23, 2003. Regulation: 8.