SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)

SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) is an FDA 510(k)-cleared medical device (K961534) 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.