ENZYGNOST ANTI-CMV IGM TEST

ENZYGNOST ANTI-CMV IGM TEST is an FDA 510(k)-cleared medical device (K861363) 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 July 20, 1986. Regulation: 8.