SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM

SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM is an FDA 510(k)-cleared medical device (K961553) 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 May 19, 1996. Regulation: 8.