FDA device listing
BJP,Vivafree 2; Vivafree 500; Vivaspin 20; Vivaspin 15; Vivaspin 6; Vivaspin 4
FDA device listing 1421078000 · Vivaproducts
Key facts
| Proprietary names | BJP,Vivafree 2; Vivafree 500; Vivaspin 20; Vivaspin 15; Vivaspin 6; Vivaspin 4 |
|---|---|
| Owner/operator | Vivaproducts |
| Owner/operator number | 10050765 |
| Product codes | JJH |
| Device names | JJH - Clinical Sample Concentrator |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2310 |
| Review panels | Clinical Chemistry |
| Registered establishments | VIVAPRODUCTS, INC. |
| Establishment registrations | 1224838 |
| FEI numbers | 1000513605 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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