FDA device listing
Anti-Schistosoma ELISA (IgG),Anti-Schistosoma mansoni IFA (IgG)
FDA device listing 1933289516 · EUROIMMUN Medizinische Labordiagnostika AG
Key facts
| Proprietary names | Anti-Schistosoma ELISA (IgG),Anti-Schistosoma mansoni IFA (IgG) |
|---|---|
| Owner/operator | EUROIMMUN Medizinische Labordiagnostika AG |
| Owner/operator number | 10025212 |
| Product codes | GNH |
| Device names | GNH - Antigen, Fluorescent Antibody Test, Schistosoma Mansoni |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3600 |
| Review panels | Microbiology |
| Registered establishments | EUROIMMUN Medizinische Labordiagnostika AG, EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG |
| Establishment registrations | 3003268355, 3007361513 |
| FEI numbers | 3003268355, 3007361513 |
| 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