FDA device listing
AFP CalSet II,AFP G2 CS Elecsys V3,AMH CS Elecsys V2,Androstenedione CS Elecsys,Anti-TSHR CS Elecsys…
FDA device listing 1044050119 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | AFP CalSet II,AFP G2 CS Elecsys V3,AMH CS Elecsys V2,Androstenedione CS Elecsys,Anti-TSHR CS Elecsys V2,beta-Amyloid(1-42) G2 CS Elecsys,Calcitonin CS Elecsys V2,CalSet ?-Amyloid (1-42) II,CalSet Androstenedione,CalSet Anti-TSHR,CalSet Cortisol III Urine,CalSet IGF-1,CalSet IGFBP-3,CalSet Phospho-Tau (181P),CalSet Phospho-Tau (181P) Plasma,CalSet Total-Tau,CalSet Vitamin D total III,Cortisol III… |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | JIT |
| Device names | JIT - Calibrator, Secondary |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE DIAGNOSTICS GMBH |
| Establishment registrations | 9610126 |
| FEI numbers | 3002806559 |
| Establishment operations | 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