FDA device listing
Dimension FT3 Flex,Dimension Vista FT3 Flex,IMMULITE 2000 Total T3 (T3),MAGIC LITE T3 100 TEST KIT
FDA device listing 1258890966 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Dimension FT3 Flex,Dimension Vista FT3 Flex,IMMULITE 2000 Total T3 (T3),MAGIC LITE T3 100 TEST KIT |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| 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 | Siemens Healthcare Diagnostics Inc., SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Establishment registrations | 1219913, 2432235, 2517506 |
| FEI numbers | 1219913, 2432235, 2517506 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer, Repackager/Relabeler |
| 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