FDA device listing
CD34 Separation System
FDA device listing 1236898861 · Miltenyi Biotec/Dinsmore
Key facts
| Proprietary names | CD34 Separation System |
|---|---|
| Owner/operator | Miltenyi Biotec/Dinsmore |
| Owner/operator number | 10031807 |
| Premarket submissions | BH110018 |
| Product codes | OVG |
| Device names | OVG - Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) |
| Device class | HDE |
| Classification regulations (21 CFR) | ORCA1.OVG |
| Review panels | Hematology |
| Registered establishments | Miltenyi Biotec B. V. & Co. KG, Miltenyi Biotec B. V. & Co. KG Branch Teterow |
| Establishment registrations | 3005290010, 3008264130 |
| FEI numbers | 3004112148, 3008264130 |
| Establishment operations | Manufacturer |
| 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