FDA device listing
Total Triiodothyronine test (Chemiluminescence Immunoassay)
FDA device listing 1916058858 · Beijing Hotgen Biotech Co., Ltd.
Key facts
| Proprietary names | Total Triiodothyronine test (Chemiluminescence Immunoassay) |
|---|---|
| Owner/operator | Beijing Hotgen Biotech Co., Ltd. |
| Owner/operator number | 10084151 |
| Product codes | CDP |
| Device names | CDP - Radioimmunoassay, Total Triiodothyronine |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1710 |
| Review panels | Clinical Chemistry |
| Registered establishments | BEIJING HOTGEN BIOTECH CO., LTD. |
| Establishment registrations | 3017894300 |
| FEI numbers | 3017894300 |
| 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