FDA device listing
TENDIGO Cat No. 80412,TENDIGO Disposable Trays Cat no. 80421
FDA device listing 1064490153 · Fujirebio Diagnostics, Inc.
Key facts
| Proprietary names | TENDIGO Cat No. 80412,TENDIGO Disposable Trays Cat no. 80421 |
|---|---|
| Owner/operator | Fujirebio Diagnostics, Inc. |
| Owner/operator number | 10022860 |
| Product codes | JJE |
| Device names | JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | Fujirebio Europe N.V. |
| Establishment registrations | 9615837 |
| FEI numbers | 3002608770 |
| Establishment operations | Foreign Exporter, 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