FDA device listing
CRYOCHECK Factor IX Deficient Plasma
FDA device listing 1115525074 · Precision BioLogic
Key facts
| Proprietary names | CRYOCHECK Factor IX Deficient Plasma |
|---|---|
| Owner/operator | Precision BioLogic |
| Owner/operator number | 9002573 |
| Premarket submissions | K971226 |
| Product codes | GJT |
| Device names | GJT - Plasma, Coagulation Factor Deficient |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7290 |
| Review panels | Hematology |
| Registered establishments | Precision BioLogic Inc. |
| Establishment registrations | 8043599 |
| FEI numbers | 3005917516 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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