
Roche Diagnostics Corporation
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AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY is an FDA 510(k)-cleared medical device (K070174) manufactured by Roche Diagnostics Corporation. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 15, 2007. Regulation: 8.