FDA device listing
Kit Dispenser for 945 ML RCCM Bottle,Kit Roche Cell Collection Medium 20 ML,Kit Roche Cell CollectionMedium 945 ML
FDA device listing 1626699749 · Thermo Fisher Scientific
Key facts
| Proprietary names | Kit Dispenser for 945 ML RCCM Bottle,Kit Roche Cell Collection Medium 20 ML,Kit Roche Cell CollectionMedium 945 ML |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | KET |
| Device names | KET - Filters, Cell Collection, Tissue Processing |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3010 |
| Review panels | Pathology |
| Registered establishments | Fisher Diagnostics |
| Establishment registrations | 1181121 |
| FEI numbers | 1181121 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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