cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System is an FDA 510(k)-cleared medical device (K223591) 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 July 26, 2023. Regulation: 8.