
Microgenics Corp.
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CEDIA(R) CARBAMAZEPINE ASSAY is an FDA 510(k)-cleared medical device (K914857) 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 January 14, 1992. Regulation: 8.