FDA device listing
AFP ELISA
FDA device listing 2011468206 · ImmunoCentrix Corporation
Key facts
| Proprietary names | AFP ELISA |
|---|---|
| Owner/operator | ImmunoCentrix Corporation |
| Owner/operator number | 10084773 |
| Product codes | NSF |
| Device names | NSF - Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.6030 |
| Review panels | Immunology |
| Registered establishments | IMMUNOCENTRIX CORPORATION |
| Establishment registrations | 3022178699 |
| FEI numbers | 3022178699 |
| 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