OVG

Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

Product code

OVG

Device name

Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

Device class

Class F

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

FDA classification definition

For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).