RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE

RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE is an FDA 510(k)-cleared medical device (K890089) 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 March 12, 1989. Regulation: 8.