FDA device listing
VACUETTE® Urine CCM Tube+Urine Cup with Transfer Device,VACUETTE® Urine CCM Tube+Urine STB Tube+Urine Cup with Transfer…
FDA device listing 1720877357 · GREINER BIO-ONE NA
Key facts
| Proprietary names | VACUETTE® Urine CCM Tube+Urine Cup with Transfer Device,VACUETTE® Urine CCM Tube+Urine STB Tube+Urine Cup with Transfer Device,VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Cup with Transfer Device,VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Transfer Device |
|---|---|
| Owner/operator | GREINER BIO-ONE NA |
| Owner/operator number | 8020040 |
| Product codes | OIE |
| Device names | OIE - Urine Collection Kit (Excludes Hiv Testing) |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | GREINER BIO-ONE GMBH |
| Establishment registrations | 8020040 |
| FEI numbers | 3000974732 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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