FDA device listing
ALINITY H-SERIES MAY-GRUNWALD-GIEMSA STAIN,ALINITY H-SERIES WRIGHT GIEMSA STAIN
FDA device listing 1634498326 · AVANTOR PERFORMANCE MATERIALS, LLC
Key facts
| Proprietary names | ALINITY H-SERIES MAY-GRUNWALD-GIEMSA STAIN,ALINITY H-SERIES WRIGHT GIEMSA STAIN |
|---|---|
| Owner/operator | AVANTOR PERFORMANCE MATERIALS, LLC |
| Owner/operator number | 9003640 |
| Product codes | GJL |
| Device names | GJL - Romanowsky Stains |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| Registered establishments | Avantor Performance Materials Poland S.A. |
| Establishment registrations | 3011558129 |
| FEI numbers | 3011558129 |
| Establishment operations | Contract 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