FDA device listing
Papanicolaou Stain EA-36-50,Papanicolaou Stain EA-65,Papanicolaou Stain, Gill's Modified EA Formula,Papanicolaou Stain…
FDA device listing 1000092917 · RICCA CHEMICAL COMPANY LLC
Key facts
| Proprietary names | Papanicolaou Stain EA-36-50,Papanicolaou Stain EA-65,Papanicolaou Stain, Gill's Modified EA Formula,Papanicolaou Stain, Gill's Modified OG-6 Formula,Papanicolaou Stain OG-6 |
|---|---|
| Owner/operator | RICCA CHEMICAL COMPANY LLC |
| Owner/operator number | 1625587 |
| Product codes | HZJ |
| Device names | HZJ - Stain, Papanicolau |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| Registered establishments | RICCA CHEMICAL COMPANY LLC |
| Establishment registrations | 1125908, 1625587, 3006365273 |
| FEI numbers | 1625587, 3003103936, 3006365273 |
| 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