FDA device listing
FSH One Step Menopause Test Midstream,FSH One Step Menopause Test Strip,FSH One Step Menopause Cassette,Vivoo At-Home…
FDA device listing 1100350202 · SEJOY BIOMEDICAL CO., LTD.
Key facts
| Proprietary names | FSH One Step Menopause Test Midstream,FSH One Step Menopause Test Strip,FSH One Step Menopause Cassette,Vivoo At-Home Fertility Test |
|---|---|
| Owner/operator | SEJOY BIOMEDICAL CO., LTD. |
| Owner/operator number | 9078355 |
| 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 | SEJOY BIOMEDICAL CO., LTD. |
| Establishment registrations | 3005395953 |
| FEI numbers | 3005395953 |
| 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