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Gen-Probe, Inc.
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GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS is an FDA 510(k)-cleared medical device (K043072) 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 January 26, 2005. Regulation: 8.