FDA device listing
VITROS Liquid Performance Verifiers
FDA device listing 1949666447 · QuidelOrtho Corporation
Key facts
| Proprietary names | VITROS Liquid Performance Verifiers |
|---|---|
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| Premarket submissions | K903189 |
| Product codes | DIF |
| Device names | DIF - Drug Mixture Control Materials |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.3280 |
| Review panels | Clinical Toxicology |
| Registered establishments | Ortho-Clinical Diagnostics European Support Center, ORTHO-CLINICAL DIAGNOSTICS, INC., Ortho Clinical Diagnostics, K.K., Ortho-Clinical Diagnostics Singapore Pte Ltd |
| Establishment registrations | 1319681, 1319808, 2250051, 3000308930, 3002642396, 3012963943 |
| FEI numbers | 2250051, 1000136573, 1000305841, 3000308930, 3002642396, 3012963943 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| 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