Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System is an FDA 510(k)-cleared medical device (K221160) 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 June 6, 2022. Regulation: 8.