FDA device listing
VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Pr
FDA device listing 2055265026 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Pr |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K101234 |
| Product codes | OWF |
| Device names | OWF - Immunohistochemical Assay, Helicobacter Pylori |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3110 |
| Review panels | Microbiology |
| Registered establishments | VENTANA MEDICAL SYSTEMS, INC. |
| Establishment registrations | 2028492 |
| FEI numbers | 1000125183 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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