FDA device listing
Blue-Ral 555,Eosine-Ral 555,Fix-Ral 555,Giemsa solution for SP Automated systems,May Grunwald solution for SP Automated…
FDA device listing 1500764967 · Ral Diagnostics
Key facts
| Proprietary names | Blue-Ral 555,Eosine-Ral 555,Fix-Ral 555,Giemsa solution for SP Automated systems,May Grunwald solution for SP Automated systems,SP cleaning solution,Wright Giemsa solution for SP Automated systems |
|---|---|
| Owner/operator | Ral Diagnostics |
| Owner/operator number | 10079788 |
| Product codes | GJL |
| Device names | GJL - Romanowsky Stains |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| Registered establishments | RAL DIAGNOSTICS |
| Establishment registrations | 3009000266 |
| FEI numbers | 3009000266 |
| 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