ENZYGNOST(R) TOXOPLASMOSIS/IGG

ENZYGNOST(R) TOXOPLASMOSIS/IGG is an FDA 510(k)-cleared medical device (K913731) 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 April 28, 1992. Regulation: 8.