FDA device listing
ARUP1MDF,CMC1OUNF,MDRGN4F,Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam durlobactam in…
FDA device listing 1412318778 · Thermo Fisher Scientific
Key facts
| Proprietary names | ARUP1MDF,CMC1OUNF,MDRGN4F,Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam durlobactam in dil range 0.015/4-32/4 µg/mL |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K231994 |
| Product codes | JWY |
| Device names | JWY - Manual Antimicrobial Susceptibility Test Systems |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.1640 |
| Review panels | Microbiology |
| Registered establishments | REMEL EUROPE LTD, TREK DIAGNOSTIC SYSTEMS, LTD. |
| Establishment registrations | 8021914, 3003750284 |
| FEI numbers | 3002806332, 3003750284 |
| 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