FDA device listing
VITROS Immunodiagnostic Products Syphilis Calibrator,VITROS Immunodiagnostic Products Syphilis Controls,VITROS…
FDA device listing 1622209578 · QuidelOrtho Corporation
Key facts
| Proprietary names | VITROS Immunodiagnostic Products Syphilis Calibrator,VITROS Immunodiagnostic Products Syphilis Controls,VITROS Immunodiagnostic Products Syphilis Reagent Pack |
|---|---|
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| Premarket submissions | K241534 |
| Product codes | LIP |
| Device names | LIP - Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3830 |
| Review panels | Microbiology |
| Registered establishments | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Establishment registrations | 1319681 |
| FEI numbers | 1000136573 |
| 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