TORCH BIO-BEAD SCREEN KIT

TORCH BIO-BEAD SCREEN KIT is an FDA 510(k)-cleared medical device (K791618) manufactured by Litton Bionetics. 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 12, 1979. Regulation: 8.