Xpert Xpress CoV-2/Flu/RSV plus

Xpert Xpress CoV-2/Flu/RSV plus is an FDA 510(k)-cleared medical device (K250995) manufactured by Cepheid®. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2025. Regulation: 8.