FDA device listing
cobas e-ELECSYS VITAMIN B12 GEN.2,Elecsys Vitamin B12,ELECSYS VITAMIN B12 CALSET GEN 2,Vitamin B12 CC 3 Elecsys,Vitamin…
FDA device listing 1102690801 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas e-ELECSYS VITAMIN B12 GEN.2,Elecsys Vitamin B12,ELECSYS VITAMIN B12 CALSET GEN 2,Vitamin B12 CC 3 Elecsys,Vitamin B12 Elecsys cobas e 100 V2,Vitamin B12 G2 CS Elecsys,VITAMIN B12 IMMUNOASSAY |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K060755 |
| Product codes | CDD, JIT, JJX |
| Device names | CDD - Radioassay, Vitamin B12, JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 862.1810 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE DIAGNOSTICS GMBH |
| Establishment registrations | 9610126 |
| FEI numbers | 3002806559 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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