
Roche Diagnostics Corp.
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COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS is an FDA 510(k)-cleared medical device (K053287) manufactured by Roche Diagnostics Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 9, 2006. Regulation: 8.