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 (K153544) manufactured by Iquum, 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 24, 2016. Regulation: 8.