FDA device listing
7102-44 VERSATREK REDOX 1, 80 ML W/STIR BAR,7103-44M VERSATREK REDOX 2M 80ML,7103-44 VERSATREK REDOX 2, 80ML,7104-44…
FDA device listing 1910580001 · Thermo Fisher Scientific
Key facts
| Proprietary names | 7102-44 VERSATREK REDOX 1, 80 ML W/STIR BAR,7103-44M VERSATREK REDOX 2M 80ML,7103-44 VERSATREK REDOX 2, 80ML,7104-44 VERSATREK REDOX 80ML TWIN-PACK,7106-44 VERSATREK REDOX 1, 40 ML W/STIR BAR,7107-44 VERSATREK REDOX 2, EZ DRAW 40ML,7110-44 VERSATREK REDOX 2M, EZ DRAW 40ML,7111-42M VERSATREK MYCO BOTTLES, W/MODIFIED CAP,7111-42 VERSATREK MYCO BOTTLES,7112-42 VERSATREK MYCO GS,7113-42 VERSATREK MYCO… |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K032306 |
| Product codes | MDB |
| Device names | MDB - System, Blood Culturing |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2560 |
| Review panels | Microbiology |
| Registered establishments | Remel Cleveland, A Division of Remel Inc., REMEL, INC. |
| Establishment registrations | 1530126, 1924669 |
| FEI numbers | 1924669, 1000515493 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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