ENZYGNOST + ANTI-CMV IGG TEST

ENZYGNOST + ANTI-CMV IGG TEST is an FDA 510(k)-cleared medical device (K852478) 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 September 15, 1985. Regulation: 8.