Cepheid Xpert C. difficile/Epi Control Panel

Cepheid Xpert C. difficile/Epi Control Panel is an FDA 510(k)-cleared medical device (K190463) manufactured by Microbiologics, 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 April 18, 2019. Regulation: 8.