Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is an FDA 510(k)-cleared medical device (K163085) manufactured by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2017. Regulation: 8.