SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM

SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM is an FDA 510(k)-cleared medical device (K953316) manufactured by Sa Scientific, 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 3, 1995. Regulation: 8.