
Ventana Medical Systems, Inc.
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VENTANA CD30 (Ber-H2) RxDx Assay is an FDA 510(k)-cleared medical device (K172471) manufactured by Ventana Medical Systems, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 7, 2018. Regulation: 8.