FDA device listing
CL0009 EDI™Infliximab CLIA Kit,CL0010 EDI™Anti-Infliximab CLIA Kit
FDA device listing 1494967022 · EPITOPE DIAGNOSTICS, INC.
Key facts
| Proprietary names | CL0009 EDI™Infliximab CLIA Kit,CL0010 EDI™Anti-Infliximab CLIA Kit |
|---|---|
| Owner/operator | EPITOPE DIAGNOSTICS, INC. |
| Owner/operator number | 9059077 |
| Product codes | QXT |
| Device names | QXT - Infliximab Test System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3115 |
| Review panels | Clinical Toxicology |
| 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