
Roche Molecular Systems, Inc.
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cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is an FDA 510(k)-cleared medical device (DEN200015) 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 July 29, 2020. Regulation: 8.