TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO

TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO is an FDA 510(k)-cleared medical device (K920702) manufactured by Pharmacia 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 7, 1992. Regulation: 8.