FDA device listing
Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)
FDA device listing 1962227813 · BioTeke Corporation (Wuxi) Co., Ltd
Key facts
| Proprietary names | Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay) |
|---|---|
| Owner/operator | BioTeke Corporation (Wuxi) Co., Ltd |
| Owner/operator number | 10071745 |
| 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 | BIOTEKE CORPORATION (WUXI) CO., LTD |
| Establishment registrations | 3016837106 |
| FEI numbers | 3016837106 |
| 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