FDA device listing
Inhibin B Detection Kit (Chemiluminescence Immunoassay)
FDA device listing 1653763262 · DIRUI INDUSTRIAL CO., LTD.
Key facts
| Proprietary names | Inhibin B Detection Kit (Chemiluminescence Immunoassay) |
|---|---|
| Owner/operator | DIRUI INDUSTRIAL CO., LTD. |
| Owner/operator number | 9049667 |
| Product codes | NDR |
| Device names | NDR - Enzyme Immunoassay, Inhibin-A |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1260 |
| Review panels | Clinical Chemistry |
| Registered establishments | DIRUI INDUSTRIAL CO., LTD. |
| Establishment registrations | 3003741796 |
| FEI numbers | 3003741796 |
| 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