FDA device listing
BelloCell,CelCradle,CelCradle +,CelCradle X,CelCradle X Automated Cell Harvesting…
FDA device listing 1662695298 · esco bioengineering
Key facts
| Proprietary names | BelloCell,CelCradle,CelCradle +,CelCradle X,CelCradle X Automated Cell Harvesting System,CelXrocker,MiniTide,TideCell,TideWave,TideXcell,TideXcell Automated Cell Harvesting System,VXL Hybrid Bioreator |
|---|---|
| Owner/operator | esco bioengineering |
| Owner/operator number | 10087888 |
| Product codes | KJF |
| Device names | KJF - System, Suspension, Cell Culture |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.2240 |
| Review panels | Hematology |
| Registered establishments | ESCO BIOENGINEERING |
| Establishment registrations | 3006571324 |
| FEI numbers | 3006571324 |
| 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