cobas liat Bordetella panel nucleic acid test

cobas liat Bordetella panel nucleic acid test is an FDA 510(k)-cleared medical device (K243753) 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 19, 2025. Regulation: 8.