Instruments comprise the newly developed CliniMACS Prodigy
, a GMP-compliant device for fully automated cell processing and cell separation procedures, and the CliniMACS Plus Instrument
for semi-automated cell separation.
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.
Representing the next generation in automated cell processing, this GMP-compliant instrument offers advanced solutions for automating cell-processing workflows: from cell fractionation through cell culture to final product formulation.
CliniMACS Plus Instrument
CliniMACS® Plus Instrument
The CliniMACS® Plus Instrument is CE-marked for clinical use in Europe and, in conjunction with a CliniMACS Tubing Set, a CliniMACS Reagent, and the CliniMACS PBS/EDTA Buffer, can be used to separate a variety of human cell types.
Regular service of the CliniMACS® Instruments is essential to ensure that this medical device meets stringent quality control and regulatory requirements. CliniMACS Application Training courses are a valuable enhancement of the regular application training.