TOXOPLASMA IGG MICROASSAY

TOXOPLASMA IGG MICROASSAY is an FDA 510(k)-cleared medical device (K863813) manufactured by Diamedix Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 27, 1986. Regulation: 8.