ANTI-TOXOPLASMA GONDII KIT

ANTI-TOXOPLASMA GONDII KIT is an FDA 510(k)-cleared medical device (K842664) 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 August 27, 1984. Regulation: 8.