FDA device listing
AIA-PACK TT3 Calibrator Set,AIA-PACK TT3 Sample Diluting Solution,CL AIA-PACK FT3 Adjuster Set,CL AIA-PACK FT3 Test…
FDA device listing 1710298818 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | AIA-PACK TT3 Calibrator Set,AIA-PACK TT3 Sample Diluting Solution,CL AIA-PACK FT3 Adjuster Set,CL AIA-PACK FT3 Test Cup,CL AIA-PACK T3 Adjuster Set,CL AIA-PACK T3 Test Cup,ST AIA-PACK TT3 |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| 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 | TOSOH AIA, INC., TOSOH BIOSCIENCE, INC., TOSOH CORP. |
| Establishment registrations | 8031673, 9612316, 3005529799 |
| FEI numbers | 2967, 3002808328, 3005529799 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, Foreign Exporter, 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