FDA device listing
Vivoo Sediva Sedimentation Test
FDA device listing 1698653254 · Vivosens Inc
Key facts
| Proprietary names | Vivoo Sediva Sedimentation Test |
|---|---|
| Owner/operator | Vivosens Inc |
| Owner/operator number | 10085777 |
| Product codes | JPH |
| Device names | JPH - Test, Erythrocyte Sedimentation Rate |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.6700 |
| Review panels | Hematology |
| Registered establishments | VIVOSENS INC |
| Establishment registrations | 3018126397 |
| FEI numbers | 3018126397 |
| Establishment operations | Specification Developer |
| 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