FDA device listing
Multiple,R2450001 ProSpecT™ Wash Buffer
FDA device listing 1463354955 · Thermo Fisher Scientific
Key facts
| Proprietary names | Multiple,R2450001 ProSpecT™ Wash Buffer |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Product codes | LLH |
| Device names | LLH - Reagents, Clostridium Difficile Toxin |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2660 |
| Review panels | Microbiology |
| Registered establishments | OXOID AUSTRALIA PTY LIMITED, OXOID, LTD., REMEL EUROPE LTD, REMEL, INC. |
| Establishment registrations | 1924669, 8010096, 3003750284, 3006440892 |
| FEI numbers | 1924669, 3003750284, 3006224287, 3006440892 |
| Establishment operations | Foreign Exporter, Specification Developer, 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