FDA device listing
Proteus OX19 Agglutinating Sera,Proteus OX2 Agglutinating Sera,Proteus OXK Agglutinating Sera
FDA device listing 1757965357 · Thermo Fisher Scientific
Key facts
| Proprietary names | Proteus OX19 Agglutinating Sera,Proteus OX2 Agglutinating Sera,Proteus OXK Agglutinating Sera |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | GSY |
| Device names | GSY - Antisera, Fluorescent, All Globulins, Proteus Spp. |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3410 |
| Review panels | Microbiology |
| Registered establishments | REMEL EUROPE LTD |
| Establishment registrations | 3003750284 |
| FEI numbers | 3003750284 |
| Establishment operations | 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