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CliniMACS® Cell Separation System
TheraSorb™ Therapeutic Apheresis
CryoMACS® Freezing Bags
MACS® GMP Products
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Regulatory note
CliniMACS® Reagents, Tubing Sets, Instruments and PBS/EDTA Buffer are manufactured and controlled under an ISO 13485 and ISO 9001 certified quality system. In Europe, the CliniMACS System and Reagents are available as CE-marked medical devices. In the USA, CliniMACS® Reagents are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE). CliniMACS® MicroBeads are for research use only and not for use in humans.
 
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