BIOTIS (TM) SABHI (DOUBLE POUR)

BIOTIS (TM) SABHI (DOUBLE POUR) is an FDA 510(k)-cleared medical device (K874179) manufactured by Otisville Biopharm, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 27, 1988. Regulation: 8.