cobas liat CT/NG nucleic acid test

cobas liat CT/NG nucleic acid test is an FDA 510(k)-cleared medical device (K253756) 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 14, 2026. Regulation: 8.