FDA device listing
AIA-PACK TSH 3rd-Gen,AIA-PACK TSH 3rd-Gen Calibrator Set,AIA-PACK TSH 3rd-Gen Sample Diluting Solution,ST AIA-PACK TSH
FDA device listing 1798506618 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | AIA-PACK TSH 3rd-Gen,AIA-PACK TSH 3rd-Gen Calibrator Set,AIA-PACK TSH 3rd-Gen Sample Diluting Solution,ST AIA-PACK TSH |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Premarket submissions | K972586 |
| Product codes | JIS, JLW |
| Device names | JIS - Calibrator, Primary, JLW - Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1690 |
| 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
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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