FDA device listing
ECHG0130 Echinococcus IgG
FDA device listing 1973462581 · Gold Standard Diagnostics
Key facts
| Proprietary names | ECHG0130 Echinococcus IgG |
|---|---|
| Owner/operator | Gold Standard Diagnostics |
| Owner/operator number | 10031124 |
| Product codes | GPF |
| Device names | GPF - Antigen, Agglutinating, Echinococcus Spp. |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3200 |
| Review panels | Microbiology |
| Registered establishments | Gold Standard Diagnostics Frankfurt GmbH |
| Establishment registrations | 3008191245 |
| FEI numbers | 3008191245 |
| 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