FDA device listing
VENTANA HER2 DISH DNA PRB CKT-US Export
FDA device listing 1439693033 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | VENTANA HER2 DISH DNA PRB CKT-US Export |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | NYQ |
| Device names | NYQ - Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.1890 |
| Review panels | Pathology |
| Registered establishments | VENTANA MEDICAL SYSTEMS, INC. |
| Establishment registrations | 2028492 |
| FEI numbers | 1000125183 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database