FDA device listing
Staphytect Plus,Staphytect Plus Control Latex,Staphytect Plus Tests Latex
FDA device listing 1588239832 · Thermo Fisher Scientific
Key facts
| Proprietary names | Staphytect Plus,Staphytect Plus Control Latex,Staphytect Plus Tests Latex |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K972030 |
| Product codes | JWX |
| Device names | JWX - Kit, Screening, Staphylococcus Aureus |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2660 |
| Review panels | Microbiology |
| Registered establishments | OXOID, LTD., REMEL EUROPE LTD |
| Establishment registrations | 8010096, 3003750284 |
| FEI numbers | 3003750284, 3006224287 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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