FDA device listing
Sofia Analyzer,Sofia Influenza A+B FIA,Sofia Installation Pack
FDA device listing 1303453503 · QuidelOrtho Corporation
Key facts
| Proprietary names | Sofia Analyzer,Sofia Influenza A+B FIA,Sofia Installation Pack |
|---|---|
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| Premarket submissions | K112177 |
| Product codes | KHO, PSZ |
| Device names | KHO - Fluorometer, For Clinical Use, PSZ - Devices Detecting Influenza A, B, And C Virus Antigens |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.2560, 866.3328 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | Ortho-Clinical Diagnostics, Inc., QUIDEL CORP. |
| Establishment registrations | 2024674, 3021090658, 3033751096 |
| FEI numbers | 2024674, 3021090658, 3033751096 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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