APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM is an FDA 510(k)-cleared medical device (K061413) 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 October 12, 2006. Regulation: 8.