
Ventana Medical Systems, Inc.
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VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) is an FDA 510(k)-cleared medical device (DEN240025) manufactured by Ventana Medical 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 December 4, 2024. Regulation: 8.