BIOTIS (TM) HAEMOPHILUS DUCREYI

BIOTIS (TM) HAEMOPHILUS DUCREYI is an FDA 510(k)-cleared medical device (K874176) 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 February 4, 1988. Regulation: 8.