Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Country not established
- Devices
- 3
Catalogue
VENTANA PTEN (SP218) RxDx Assay Ref P250031
VENTANA MET (SP44) RxDx Assay Ref P240037
What Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) makes
Ventana Medical Systems produces in vitro diagnostic assays for immunohistochemistry, including the VENTANA MET (SP44) assay and the VENTANA MMR RxDx Panel for solid tumors. These assays detect specific biomarkers in tissue samples to assist in diagnosing and classifying cancer types, such as microsatellite instability and mismatch repair status. The MET assay targets protein expression linked to tumor progression, while the MMR panel evaluates genetic stability markers in tumors.
The company’s diagnostic assays fall under FDA Class III devices, requiring Premarket Approval (PMA) authorization. These products are listed in the FDA’s PMA registry and are intended for use in clinical laboratories and pathology settings. The manufacturer operates under U.S. regulatory oversight, adhering to stringent requirements for high-risk medical devices.
Frequently asked questions
How many devices does Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) have in the registry?
The registry currently lists 3 devices for Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). Devices recorded under merged duplicate company entries are counted once.
Which registries list Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)'s devices?
Among its 3 most recently registered devices, Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) has devices listed in FDA PMA (3 devices).
What risk classes do Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) in the registry?
The most recently registered devices listed for Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) include VENTANA PTEN (SP218) RxDx Assay, VENTANA MET (SP44) RxDx Assay and VENTANA MMR RxDx Panel Solid Tumors with dMMR status).