MB/BACT MYCROBACTERIA DETECTION SYSTEM

MB/BACT MYCROBACTERIA DETECTION SYSTEM is an FDA 510(k)-cleared medical device (K954468) manufactured by Organon Teknika Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 21, 1996. Regulation: 8.