cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System is an FDA 510(k)-cleared medical device (K223783) 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 December 3, 2023. Regulation: 8.