COBAS CT/NG V2.0 TEST

COBAS CT/NG V2.0 TEST is an FDA 510(k)-cleared medical device (K140887) 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 4, 2014. Regulation: 8.