FDA device listing
CL AIA-PACK CA 125 Adjuster Set,CL AIA-PACK CA 125 Test Cup
FDA device listing 1846585948 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | CL AIA-PACK CA 125 Adjuster Set,CL AIA-PACK CA 125 Test Cup |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Product codes | LTK |
| Device names | LTK - Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.6010 |
| Review panels | 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
- 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