BACTIGEN SALMONELLA-SHIGELLA TEST

BACTIGEN SALMONELLA-SHIGELLA TEST is an FDA 510(k)-cleared medical device (K870813) manufactured by Armkel, LLC. 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 21, 1987. Regulation: 8.