FDA device listing
INFINITE 200,INFINITE 200 PRO,INFINITE 200 PRO - INFINITE F Nano+,INFINITE 200 PRO - INFINITE F Plex,INFINITE 200 PRO…
FDA device listing 1800906875 · Tecan Group AG
Key facts
| Proprietary names | INFINITE 200,INFINITE 200 PRO,INFINITE 200 PRO - INFINITE F Nano+,INFINITE 200 PRO - INFINITE F Plex,INFINITE 200 PRO - INFINITE Lumi,INFINITE 200 PRO - INFINITE M Nano,INFINITE 200 PRO - INFINITE M Nano+,INFINITE 200 PRO - INFINITE M Plex,INFINITE F200 MICROPLATE FLUORESCENCE READER,INFINITE F500,INFINITE M1000,INFINITE M1000 PRO |
|---|---|
| Owner/operator | Tecan Group AG |
| Owner/operator number | 9050992 |
| Product codes | KHO |
| Device names | KHO - Fluorometer, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2560 |
| Review panels | Clinical Chemistry |
| Registered establishments | TECAN AUSTRIA GMBH, Tecan Trading AG |
| Establishment registrations | 3002710220, 3003559191 |
| FEI numbers | 3002710220, 3003559191 |
| Establishment operations | Complaint File Establishment, 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