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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CliniMACS® CD34 Reagent System

HDE Number:  BH110018
Device Name:  CliniMACS® CD34 Reagent System
Manufacturer: Miltenyi Biotech, Inc.

  •  The CliniMACS® CD34 Reagent System is indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission.