ENZYGNOST(R) ANTI-CMV/IGM

ENZYGNOST(R) ANTI-CMV/IGM is an FDA 510(k)-cleared medical device (K913693) 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 February 26, 1992. Regulation: 8.