FDA device listing
Ancylostoma Microwell ELISA Kit,Angiostrongylus Microwell ELISA Kit,Ascaris Microwell ELISA Kit,Clonorchis Microwell…
FDA device listing 1818707107 · Eiger Diagnostics, Inc.
Key facts
| Proprietary names | Ancylostoma Microwell ELISA Kit,Angiostrongylus Microwell ELISA Kit,Ascaris Microwell ELISA Kit,Clonorchis Microwell ELISA Kit,Echinococcus Microwell ELISA Kit,E. histolytica Microwell ELISA Kit,Fasciola gigantica Microwell ELISA Kit,Fasciola hepatica Microwell ELISA Kit,Filariasis Microwell ELISA Kit,Gnathostoma Microwell ELISA Kit,Leptospira Microwell ELISA Kit,Opisthorchis Microwell ELISA… |
|---|---|
| Owner/operator | Eiger Diagnostics, Inc. |
| Owner/operator number | 10087288 |
| Product codes | LIB |
| Device names | LIB - Device, General Purpose, Microbiology, Diagnostic |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2660 |
| Review panels | Microbiology |
| Registered establishments | EIGER DIAGNOSTICS, INC. |
| Establishment registrations | 3026241718 |
| FEI numbers | 3026241718 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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