FDA device listing
ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens,ADVIA Centaur XPT Tumor Marker Quality Controls…
FDA device listing 1508983017 · Fujirebio Diagnostics, Inc.
Key facts
| Proprietary names | ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens,ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens,Alinity i CYFRA 21-1 Controls,Alinity i CYFRA 21-1 Controls (China),Alinity i CYFRA 21-1 Controls (ROW),Alinity i Methotrexate Controls (China),Alinity i Methotrexate Controls (ROW),Alinity i Methotrexate Extended Range Controls (China),Alinity i Methotrexate… |
|---|---|
| Owner/operator | Fujirebio Diagnostics, Inc. |
| Owner/operator number | 10022860 |
| Product codes | JJX |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | Fujirebio Diagnostics, Inc., Fujirebio Europe N.V., Fujirebio Inc. |
| Establishment registrations | 1643621, 2521625, 9615837, 3002895169 |
| FEI numbers | 1643621, 2521625, 3002608770, 3002895169 |
| Establishment operations | Contract Manufacturer, 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