FDA device listing
VITROS Calibrator Kit 31,VITROS HbA1c Reagent Kit,VITROS Percent A1c Performance Verifiers
FDA device listing 1509093750 · QuidelOrtho Corporation
Key facts
| Proprietary names | VITROS Calibrator Kit 31,VITROS HbA1c Reagent Kit,VITROS Percent A1c Performance Verifiers |
|---|---|
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| Premarket submissions | K142595 |
| Product codes | JIT, JJY, PDJ |
| Device names | JIT - Calibrator, Secondary, JJY - Multi-Analyte Controls, All Kinds (Assayed), PDJ - Hemoglobin A1c Test System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1373, 862.1660 |
| Review panels | Clinical Chemistry |
| 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, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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