FDA device listing
ST AIA-PACK AFP,ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION
FDA device listing 1199035637 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | ST AIA-PACK AFP,ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Premarket submissions | K023894 |
| Product codes | JIS, LOJ |
| Device names | JIS - Calibrator, Primary, LOJ - Kit, Test,Alpha-Fetoprotein For Testicular Cancer |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 866.6010 |
| Review panels | Clinical Chemistry, Immunology |
| 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