FDA device listing
V8 Nexus Electrophoresis Instrument,V8 UltraCE Electrophoresis Instrument
FDA device listing 1828476922 · Helena Biosciences Europe
Key facts
| Proprietary names | V8 Nexus Electrophoresis Instrument,V8 UltraCE Electrophoresis Instrument |
|---|---|
| Owner/operator | Helena Biosciences Europe |
| Owner/operator number | 10041365 |
| Product codes | CEF |
| Device names | CEF - Electrophoretic, Protein Fractionation |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1630 |
| Review panels | Clinical Chemistry |
| Registered establishments | Helena Laboratories UK Ltd, Prince Technologies B.V. |
| Establishment registrations | 3009736003, 3012924127 |
| FEI numbers | 3009736003, 3012924127 |
| Establishment operations | Contract Manufacturer, 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