FDA device listing
CVSHealth,Eveline,PixoTest
FDA device listing 1290123714 · iXensor Co Ltd
Key facts
| Proprietary names | CVSHealth,Eveline,PixoTest |
|---|---|
| Owner/operator | iXensor Co Ltd |
| Owner/operator number | 10048224 |
| Product codes | NGE |
| Device names | NGE - Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1485 |
| Review panels | Clinical Chemistry |
| Registered establishments | IXENSOR CO LTD, iXensor USA Inc |
| Establishment registrations | 3011061417, 3017548799 |
| FEI numbers | 3011061417, 3017548799 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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