FDA device listing
SKT-029 Human Carcinoembryonic Antigen CLIA Kit
FDA device listing 1556643303 · EPITOPE DIAGNOSTICS, INC.
Key facts
| Proprietary names | SKT-029 Human Carcinoembryonic Antigen CLIA Kit |
|---|---|
| Owner/operator | EPITOPE DIAGNOSTICS, INC. |
| Owner/operator number | 9059077 |
| Product codes | DHX |
| Device names | DHX - System, Test, Carcinoembryonic Antigen |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.6010 |
| Review panels | Immunology |
| Registered establishments | EPITOPE DIAGNOSTICS, INC. |
| Establishment registrations | 2032839 |
| FEI numbers | 3004185580 |
| 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