FDA device listing
Elecsys IL-6,IL-6 CalSet,IL 6 CS Elecsys,IL 6 Elecsys cobas e 100,IL 6 Elecsys E2G 100
FDA device listing 1651934452 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | Elecsys IL-6,IL-6 CalSet,IL 6 CS Elecsys,IL 6 Elecsys cobas e 100,IL 6 Elecsys E2G 100 |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | QLC |
| Device names | QLC - Interleukin 6 |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QLC |
| Review panels | Immunology |
| 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