cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is an FDA 510(k)-cleared medical device (K240867) 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 10, 2025. Regulation: 8.