AMIZYME-TOXOPLASMA GONDII KIT

AMIZYME-TOXOPLASMA GONDII KIT is an FDA 510(k)-cleared medical device (K842528) manufactured by Amico Lab, 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 September 6, 1984. Regulation: 8.