FDA device listing
Buffered Wright-Giemsa Stain,Giemsa Stain,Jenner Stain,Kwik-Diff™ Solution 1,Kwik-Diff™ Solution 2,Kwik-Diff Solution…
FDA device listing 1060340467 · Epredia Holdings Ltd.
Key facts
| Proprietary names | Buffered Wright-Giemsa Stain,Giemsa Stain,Jenner Stain,Kwik-Diff™ Solution 1,Kwik-Diff™ Solution 2,Kwik-Diff Solution 3,Kwik-Diff™ Stain Kit,May-Grunwald Stain,Modified Wright-Giemsa Stain Pack,Rapid-Chrome™ Kwik-Diff™ Staining Kit,Three-Step Stain Fixative,Three-Step Stain Solution A,Three-Step Stain Solution B,Wright-Giemsa Stain,Wright-Giemsa Stain Kit |
|---|---|
| Owner/operator | Epredia Holdings Ltd. |
| Owner/operator number | 10062642 |
| Product codes | HYF |
| Device names | HYF - Giemsa Stain |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| Registered establishments | RICHARD-ALLAN SCIENTIFIC LLC |
| Establishment registrations | 1831638 |
| FEI numbers | 1831638 |
| Establishment operations | Contract Manufacturer, 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