SERODOT TOXOPLASMA IGG TEST KIT

SERODOT TOXOPLASMA IGG TEST KIT is an FDA 510(k)-cleared medical device (K875363) manufactured by Disease Detection International, 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 20, 1988. Regulation: 8.