ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST

ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST is an FDA 510(k)-cleared medical device (K904463) manufactured by Gen-Probe, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 12, 1990. Regulation: 8.