cobas CTNG for use on cobas 6800/8800 systems

cobas CTNG for use on cobas 6800/8800 systems is an FDA 510(k)-cleared medical device (K202408) 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 January 20, 2021. Regulation: 8.