cobas CT/NG for use on cobas 6800/8800 systems

cobas CT/NG for use on cobas 6800/8800 systems is an FDA 510(k)-cleared medical device (K173887) 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 March 20, 2018. Regulation: 8.