FDA device listing
F and A2 Calibrator Set 2,G11 ?-thal Elution Buffer No. 1,G11 ?-thal Elution Buffer No. 2,G11 ?-thal Elution Buffer No…
FDA device listing 1882930087 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | F and A2 Calibrator Set 2,G11 ?-thal Elution Buffer No. 1,G11 ?-thal Elution Buffer No. 2,G11 ?-thal Elution Buffer No. 3,G8 90 SL,G8 F&A2 Calibrator Set,G8 ?-thal Elution Buffer Kit,HLC-723G8,Tosoh Automated Glycohemoglobin Analyzer HLC-723G8,Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA,TSKgel G11 ?-thal,TSKgel G8 ?-thal |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Product codes | JPD |
| Device names | JPD - Hemoglobin A2 Quantitation |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7400 |
| Review panels | Hematology |
| Registered establishments | TOSOH CORP., Tosoh Hi-Tec, Inc. |
| Establishment registrations | 8031673, 3004529019 |
| FEI numbers | 2967, 3004529019 |
| 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