FDA device listing
CP112-10 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood,CP11410 Sensititre Cation Adjusted…
FDA device listing 1295192019 · Thermo Fisher Scientific
Key facts
| Proprietary names | CP112-10 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood,CP11410 Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood,Mueller Hinton Broth,T3441 Sensititre Middlebrook 7H9 Broth w/OADC,T3462-05 MUELLER-HINTON BROTH W/TES 5ml 100/BOX,T3462 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES,T3491 Sensititre Saline- Tween w/ Glass… |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K802957 |
| Product codes | JTZ |
| Device names | JTZ - Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.1700 |
| Review panels | Microbiology |
| Registered establishments | Remel Cleveland, A Division of Remel Inc., REMEL, INC., TREK DIAGNOSTIC SYSTEMS, LTD. |
| Establishment registrations | 1530126, 1924669, 8021914 |
| FEI numbers | 1924669, 1000515493, 3002806332 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| 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