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Regulatory note
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CliniMACS® System (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 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. All medical devices of the TheraSorb™ product line are manufactured and controlled under an ISO 13485 certified quality system and are CE-marked in the EU. |
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