
Roche Molecular Systems, Inc.
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cobas Factor II and Factor V Test is an FDA 510(k)-cleared medical device (K172913) manufactured by Roche Molecular Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 2018. Regulation: 8.