AMEBIASIS BIO-ENZABEAD SCREEN KIT

AMEBIASIS BIO-ENZABEAD SCREEN KIT is an FDA 510(k)-cleared medical device (K831133) manufactured by Bionetic Laboratory Products. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 1983. Regulation: 8.