ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is an FDA 510(k)-cleared medical device (K974342) manufactured by Roche Molecular Systems, 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 May 27, 1999. Regulation: 8.