Regulatory and legal notices
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. Unless otherwise specifi cally indicated, Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use.