FDA device listing
Echinococcus granulosus IgG ELISA,Echinococcus multilocularis (Em18) IgG ELISA,Echinococcus multilocularis (Em2-Em18)…
FDA device listing 1188440990 · Bordier Affinity Products
Key facts
| Proprietary names | Echinococcus granulosus IgG ELISA,Echinococcus multilocularis (Em18) IgG ELISA,Echinococcus multilocularis (Em2-Em18) IgG ELISA |
|---|---|
| Owner/operator | Bordier Affinity Products |
| Owner/operator number | 10042667 |
| 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 | BORDIER AFFINITY PRODUCTS SA |
| Establishment registrations | 3003718445 |
| FEI numbers | 3003718445 |
| 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