HDE
BH110018: CliniMACS CD34 Reagent System
FDA Humanitarian Device Exemption · Miltenyi Biotec, Inc.
Key facts
| HDE number | BH110018 |
|---|---|
| Trade name | CliniMACS CD34 Reagent System |
| Generic name | Magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml) |
| Applicant | Miltenyi Biotec, Inc. |
| Owner/operator | Miltenyi Biotec/Dinsmore |
| Product code | OVG |
| Approval date | Jan 23, 2014 |
| Establishment registration | 3003348283 |
| FEI number | 3003348283 |
At a glance
- None Supplements
- Jan 23, 2014 Latest supplement decision
- No Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 10–99 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: