FDA device listing
ST AIA-PACK Osteocalcin,ST AIA-PACK Osteocalcin Calibrator Set,ST AIA-PACK Osteocalcin Control Set,ST AIA-PACK…
FDA device listing 2007578125 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | ST AIA-PACK Osteocalcin,ST AIA-PACK Osteocalcin Calibrator Set,ST AIA-PACK Osteocalcin Control Set,ST AIA-PACK Osteocalcin Sample Diluting Solution |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Product codes | NEO |
| Device names | NEO - System, Test, Osteocalcin |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1050 |
| Review panels | Clinical Chemistry |
| Registered establishments | TOSOH AIA, INC., TOSOH CORP. |
| Establishment registrations | 8031673, 9612316 |
| FEI numbers | 2967, 3002808328 |
| Establishment operations | 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