FDA device listing
One Step Menopause Test
FDA device listing 1071367222 · SYNTRON BIORESEARCH, INC.
Key facts
| Proprietary names | One Step Menopause Test |
|---|---|
| Owner/operator | SYNTRON BIORESEARCH, INC. |
| Owner/operator number | 2025760 |
| 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 | SYNTRON BIORESEARCH, INC. |
| Establishment registrations | 2025760 |
| FEI numbers | 2025760 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, 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