FDA device listing
cobas e-ELECSYS FERRITIN [100],cobas e-ELECSYS FERRITIN [200],ELECSYS FERRITIN PRODUCTS,Ferritin CS Elecsys V2,Ferritin…
FDA device listing 1653675942 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas e-ELECSYS FERRITIN [100],cobas e-ELECSYS FERRITIN [200],ELECSYS FERRITIN PRODUCTS,Ferritin CS Elecsys V2,Ferritin Elecsys cobas e 100 V2,Ferritin Elecsys cobas e 200,Ferritin Elecsys E2G 300,Ferritin Gen.2 Elecsys,cobas e |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K971833 |
| Product codes | JMG |
| Device names | JMG - Radioimmunoassay (Two-Site Solid Phase), Ferritin |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5340 |
| 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
- 1–9 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