FDA device listing
VRE Select (stool claim)
FDA device listing 1262136034 · Bio-Rad Laboratories (Bio-Rad Services France)
Key facts
| Proprietary names | VRE Select (stool claim) |
|---|---|
| Owner/operator | Bio-Rad Laboratories (Bio-Rad Services France) |
| Owner/operator number | 10078397 |
| Premarket submissions | K122187 |
| Product codes | JSO |
| Device names | JSO - Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.1700 |
| Review panels | Microbiology |
| Registered establishments | Bio-Rad Service France SAS |
| Establishment registrations | 3035708936 |
| FEI numbers | 3035708936 |
| Establishment operations | Foreign Exporter |
| 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