FDA device listing
CL AIA-PACK LH Adjuster Set,CL AIA-PACK LH Test Cup,ST AIA-PACK LH II,ST AIA-PACK LH II Calibrator Set,ST AIA-PACK LH II…
FDA device listing 1943155388 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | CL AIA-PACK LH Adjuster Set,CL AIA-PACK LH Test Cup,ST AIA-PACK LH II,ST AIA-PACK LH II Calibrator Set,ST AIA-PACK LH II Sample Diluting Solution |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Product codes | CEP |
| Device names | CEP - Radioimmunoassay, Luteinizing Hormone |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1485 |
| 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