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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade Name CliniMACS CD34 Reagent System
Classification Namemagnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml)
Generic Namemagnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml)
Applicant
Miltenyi Biotec, Inc.
120 presidential way
suite 305
woburn, MA 01801
HDE NumberBH110018
Date Received04/12/2011
Decision Date01/23/2014
Product Code
OVG[ Registered Establishments with OVG ]
Advisory Committee Hematology
Expedited Review Granted? No
Combination ProductNo
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