COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is an FDA 510(k)-cleared medical device (K053289) manufactured by Roche Diagnostics Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 2006. Regulation: 8.