cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is an FDA 510(k)-cleared medical device (K202215) 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 1, 2020. Regulation: 8.