FDA device listing
CMV IgG Elecsys cobas e 100 V2,CMV IgG Elecsys E2G 300 V2,Elecsys CMV IgG
FDA device listing 1948111364 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | CMV IgG Elecsys cobas e 100 V2,CMV IgG Elecsys E2G 300 V2,Elecsys CMV IgG |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K220911 |
| Product codes | JJX, LFZ |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), LFZ - Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1660, 866.3175 |
| Review panels | Clinical Chemistry, Microbiology |
| 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