cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System

cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System is an FDA 510(k)-cleared medical device (K210234) 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 February 15, 2021. Regulation: 8.