BIOTIS TSA WITH 5% RABBIT BLOOD

BIOTIS TSA WITH 5% RABBIT BLOOD is an FDA 510(k)-cleared medical device (K860403) manufactured by Otisville Biotech, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 23, 1986. Regulation: 8.