
Gen-Probe, Inc.
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TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 is an FDA 510(k)-cleared medical device (K061509) manufactured by Gen-Probe, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2006. Regulation: 8.