GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA

GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA is an FDA 510(k)-cleared medical device (K864597) 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 April 19, 1987. Regulation: 8.