FDA device listing
cobas BRAF V600 Mutation Test,KIT DNA ISOLATION 24T IVD
FDA device listing 1328295118 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | cobas BRAF V600 Mutation Test,KIT DNA ISOLATION 24T IVD |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | P110020 |
| Product codes | OWD |
| Device names | OWD - Somatic Gene Mutation Detection System |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OWD |
| Review panels | Pathology |
| Registered establishments | ROCHE DIAGNOSTICS GMBH, ROCHE MOLECULAR SYSTEMS, INC. |
| Establishment registrations | 2243471, 9610126, 9610529, 3004141078 |
| FEI numbers | 2243471, 3002806559, 3002806560, 3004141078 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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