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Gen-Probe, Inc.
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GEN-PROBE APTIMA COMBO 2 ASSAY is an FDA 510(k)-cleared medical device (K032554) 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 December 30, 2003. Regulation: 8.