FDA device listing
Vacuette Blood Collection Tubes Serum with Clot Activator,Vacuette Blood Collection Tubes Serum with Clot Activator and…
FDA device listing 1139451925 · GREINER BIO-ONE NA
Key facts
| Proprietary names | Vacuette Blood Collection Tubes Serum with Clot Activator,Vacuette Blood Collection Tubes Serum with Clot Activator and Gel |
|---|---|
| Owner/operator | GREINER BIO-ONE NA |
| Owner/operator number | 8020040 |
| Premarket submissions | K960858 |
| Product codes | JKA |
| Device names | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675 |
| Review panels | Clinical Chemistry |
| Registered establishments | GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR, GREINER BIO-ONE GMBH, GREINER BIO-ONE NORTH AMERICA, INC. |
| Establishment registrations | 1125230, 8020040, 3005674478 |
| FEI numbers | 3000974732, 3001451379, 3005674478 |
| 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