FDA device listing
DiaSpect Control HBT1,DiaSpect Control HBT2,DiaSpect Control HBT3,DiaSpect Control HBT4
FDA device listing 1392164781 · EKF DIAGNOSTIC GMBH
Key facts
| Proprietary names | DiaSpect Control HBT1,DiaSpect Control HBT2,DiaSpect Control HBT3,DiaSpect Control HBT4 |
|---|---|
| Owner/operator | EKF DIAGNOSTIC GMBH |
| Owner/operator number | 9057009 |
| Product codes | GGM |
| Device names | GGM - Control, Hemoglobin |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.8625 |
| Review panels | Hematology |
| Registered establishments | EKF DIAGNOSTIC GMBH |
| Establishment registrations | 3004838836 |
| FEI numbers | 3004838836 |
| Establishment operations | Manufacturer, Specification Developer |
| 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