FDA device listing
ADVIA Centaur CA 19-9 (CA 19-9),ADVIA Centaur CA 19-9 Diluent (CA 19-9 DIL),ADVIA Centaur CA 19-9 Master Curve Material…
FDA device listing 1181116266 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | ADVIA Centaur CA 19-9 (CA 19-9),ADVIA Centaur CA 19-9 Diluent (CA 19-9 DIL),ADVIA Centaur CA 19-9 Master Curve Material (CA 19-9 MCM),Atellica IM CA 19-9 (CA 19-9),Atellica IM CA 19-9 Diluent (CA 19-9 DIL),Atellica IM CA 19-9 Master Curve Material (CA 19-9 MCM) |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K031393 |
| Product codes | JIT, NIG |
| Device names | JIT - Calibrator, Secondary, NIG - System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 866.6010 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Siemens Healthcare Diagnostics Inc. |
| Establishment registrations | 1219913, 2432235 |
| FEI numbers | 1219913, 2432235 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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