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Regulatory note
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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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Information for users in the USA. |
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