FDA device listing
DAVID One Step FSH Urine Test
FDA device listing 1474531027 · Equinox Biotech Co., Ltd.
Key facts
| Proprietary names | DAVID One Step FSH Urine Test |
|---|---|
| Owner/operator | Equinox Biotech Co., Ltd. |
| Owner/operator number | 9074282 |
| Product codes | NGA |
| Device names | NGA - Test, Follicle Stimulating Hormone (Fsh), Over The Counter |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1300 |
| Review panels | Clinical Chemistry |
| Registered establishments | Equinox Biotech Co., Ltd. |
| Establishment registrations | 3005216656 |
| FEI numbers | 3005216656 |
| 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