ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE is an FDA 510(k)-cleared medical device (K974503) 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 November 30, 1999. Regulation: 8.