FDA device listing
Coombs Control Cells,Reagent Red Blood Cells
FDA device listing 1581782123 · MEDION GRIFOLS DIAGNOSTICS AG
Key facts
| Proprietary names | Coombs Control Cells,Reagent Red Blood Cells |
|---|---|
| Owner/operator | MEDION GRIFOLS DIAGNOSTICS AG |
| Owner/operator number | 9090520 |
| Product codes | KSM |
| Device names | KSM - System, Test, Combs, Automated |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.9300 |
| Review panels | Hematology |
| Registered establishments | MEDION GRIFOLS DIAGNOSTICS AG |
| Establishment registrations | 3002806769 |
| FEI numbers | 3002806769 |
| 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