FDA device listing
Sofia 2 C. difficile FIA
FDA device listing 1529656078 · QuidelOrtho Corporation
Key facts
| Proprietary names | Sofia 2 C. difficile FIA |
|---|---|
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| Product codes | LLH |
| Device names | LLH - Reagents, Clostridium Difficile Toxin |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2660 |
| Review panels | Microbiology |
| Registered establishments | Ortho-Clinical Diagnostics, Inc., QUIDEL CORP. |
| Establishment registrations | 2024674, 3021090658, 3033751096 |
| FEI numbers | 2024674, 3021090658, 3033751096 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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