ENZYGNOST ANTI-CMV/IGG + IGM

ENZYGNOST ANTI-CMV/IGG + IGM is an FDA 510(k)-cleared medical device (K901485) manufactured by Behring Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 1991. Regulation: 8.