Xpert® Xpress CoV-2 plus

Xpert® Xpress CoV-2 plus is an FDA 510(k)-cleared medical device (K230440) 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 October 12, 2023. Regulation: 8.