FDA device listing
Special Stains Aniline Blue CS
FDA device listing 1448197294 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | Special Stains Aniline Blue CS |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | KFD |
| Device names | KFD - Aniline Blue |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| 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 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