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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
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
Supplement Number16
Date Received04/23/2015
Decision Date05/21/2015
Product Code
OVG[ Registered Establishments with OVG ]
Advisory Committee Hematology
Expedited Review Granted? No
Combination ProductNo
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