FDA device listing
Alinity i CA 19-9XR Calibrators,Alinity i CA 19-9XR Calibrators (China),Alinity i CA 19-9XR Controls,Alinity i CA 19-9XR…
FDA device listing 1220216321 · Fujirebio Diagnostics, Inc.
Key facts
| Proprietary names | Alinity i CA 19-9XR Calibrators,Alinity i CA 19-9XR Calibrators (China),Alinity i CA 19-9XR Controls,Alinity i CA 19-9XR Reagents,Alinity i CA 19-9XR Reagents (China),ARCHITECT CA 19-9XR Calibrators,ARCHITECT CA 19-9XR Calibrators (China),ARCHITECT CA 19-9XR Controls,ARCHITECT CA 19-9XR Reagents,ARCHITECT CA 19-9XR Reagents (China) |
|---|---|
| Owner/operator | Fujirebio Diagnostics, Inc. |
| Owner/operator number | 10022860 |
| 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 | Fujirebio Diagnostics, Inc. |
| Establishment registrations | 2521625 |
| FEI numbers | 2521625 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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