ENZYGNOST TOXOPLASMOSIS/IGM

ENZYGNOST TOXOPLASMOSIS/IGM is an FDA 510(k)-cleared medical device (K913505) 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 March 3, 1992. Regulation: 8.