FDA device listing
VITROS CA 19-9 Calibrator,VITROS CA 19-9 Range Verifiers,VITROS CA 19-9 Reagent Pack
FDA device listing 1118348934 · QuidelOrtho Corporation
Key facts
| Proprietary names | VITROS CA 19-9 Calibrator,VITROS CA 19-9 Range Verifiers,VITROS CA 19-9 Reagent Pack |
|---|---|
| Owner/operator | QuidelOrtho Corporation |
| Owner/operator number | 2024674 |
| Premarket submissions | K052889 |
| Product codes | JIT, JJX, NIG |
| Device names | JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), NIG - System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 866.6010 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Ortho-Clinical Diagnostics, Ortho-Clinical Diagnostics European Support Center, ORTHO-CLINICAL DIAGNOSTICS, INC., Ortho Clinical Diagnostics, K.K., Ortho-Clinical Diagnostics Singapore Pte Ltd |
| Establishment registrations | 1319681, 2250051, 3000308930, 3002642396, 3007111389, 3012963943 |
| FEI numbers | 2250051, 1000136573, 3000308930, 3002642396, 3007111389, 3012963943 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| 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