Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System is an FDA 510(k)-cleared medical device (K191729) 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 23, 2019. Regulation: 8.