cobas Cdiff nucleic acid test for use on the cobas Liat System

cobas Cdiff nucleic acid test for use on the cobas Liat System is an FDA 510(k)-cleared medical device (K210385) manufactured by Roche Molecular Systems, 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 September 8, 2021. Regulation: 8.