FDA device listing
VACUETTE Urine CCM Tube,VACUETTE Urine CCM Tube convenience kit
FDA device listing 1584681644 · GREINER BIO-ONE NA
Key facts
| Proprietary names | VACUETTE Urine CCM Tube,VACUETTE Urine CCM Tube convenience kit |
|---|---|
| Owner/operator | GREINER BIO-ONE NA |
| Owner/operator number | 8020040 |
| Premarket submissions | K163436 |
| Product codes | JSM, LIO |
| Device names | JSM - Culture Media, Non-Propagating Transport, LIO - Device, Specimen Collection |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2390, 866.2900 |
| Review panels | Microbiology |
| Registered establishments | GREINER BIO-ONE GMBH |
| Establishment registrations | 8020040 |
| FEI numbers | 3000974732 |
| Establishment operations | 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