FDA device listing
ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII),ADVIA Centaur aTPOII Diluent (aTPOII DIL),ADVIA Centaur aTPOII Master…
FDA device listing 1101659492 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII),ADVIA Centaur aTPOII Diluent (aTPOII DIL),ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM),ADVIA Centaur aTPOII Quality Control (aTPOII QC),Atellica IM Anti-Thyroid Peroxidase II (aTPOII),Atellica IM aTPOII Diluent (aTPOII DIL),Atellica IM aTPOII Master Curve Material (aTPOII MCM),Atellica IM aTPOII Quality Control (aTPOII QC) |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K250250 |
| Product codes | JIT, JJX, JZO |
| Device names | JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), JZO - System, Test, Thyroid Autoantibody |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 866.5870 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Siemens Healthcare Diagnostics Inc., SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
| Establishment registrations | 1219913, 2432235, 3002806944 |
| FEI numbers | 1219913, 2432235, 3002806944 |
| 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