Miltenyi Biotec offers you advanced integrated solutions to streamline cell processing workflows from sample preparation over cell separation, through cell culture to the final cellular product.
MACS GMP Products are for research use and ex vivo cell culture processing only, and are not intended for human in vivo applications. For regulatory status in the USA, please contact your local representative. For availability in your country please contact your local representative. The CliniMACS® System components including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer are manufactured and controlled under an ISO 13485 certified quality system. In the EU, the CliniMACS System components are available as CE-marked medical devices. In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Set TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved; all other products of the CliniMACS product line 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 human therapeutic or diagnostic use. CryoMACS® Freezing Bags are manufactured by Miltenyi Biotec GmbH and controlled under an ISO13485 certified quality system. These products are available in Europe as CE-marked medical devices and are marketed in the USA under FDA 510(k) clearance. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use.