FDA device listing
Salmonella H 1,2 Agglutinating Sera,Salmonella H 1,5 Agglutinating Sera,Salmonella H 1,6 Agglutinating Sera,Salmonella H…
FDA device listing 1985279091 · Thermo Fisher Scientific
Key facts
| Proprietary names | Salmonella H 1,2 Agglutinating Sera,Salmonella H 1,5 Agglutinating Sera,Salmonella H 1,6 Agglutinating Sera,Salmonella H 1,7 Agglutinating Sera,Salmonella H a Agglutinating Sera,Salmonella H b Agglutinating Sera,Salmonella H c Agglutinating Sera,Salmonella H d Agglutinating Sera,Salmonella H e,h Agglutinating Sera,Salmonella H e,n,x Agglutinating Sera,Salmonella H enz15 Agglutinating… |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | GRM |
| Device names | GRM - Antisera, All Groups, Salmonella Spp. |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3550 |
| Review panels | Microbiology |
| Registered establishments | OXOID AUSTRALIA PTY LIMITED, OXOID, LTD., REMEL EUROPE LTD |
| Establishment registrations | 8010096, 3003750284, 3006440892 |
| FEI numbers | 3003750284, 3006224287, 3006440892 |
| Establishment operations | Foreign Exporter, Manufacturer, 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