FDA device listing
Sensititre 20-24 hour Haemophilus influenzae/S. pneumoniae (HP) MIC/BP Susceptibility System Penicillin 0.015-32 ug/mL
FDA device listing 1945908889 · Thermo Fisher Scientific
Key facts
| Proprietary names | Sensititre 20-24 hour Haemophilus influenzae/S. pneumoniae (HP) MIC/BP Susceptibility System Penicillin 0.015-32 ug/mL |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K243201 |
| Product codes | JWY, LRG, LTT |
| Device names | JWY - Manual Antimicrobial Susceptibility Test Systems, LRG - Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, LTT - Panels, Test, Susceptibility, Antimicrobial |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.1640 |
| Review panels | Microbiology |
| Registered establishments | TREK DIAGNOSTIC SYSTEMS, LTD. |
| Establishment registrations | 8021914 |
| FEI numbers | 3002806332 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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