Device Dossier

CliniMACS CD45RA Reagent - Magnetic cell separation system reagent

Device Dossier for CliniMACS CD45RA Reagent - Magnetic cell separation system reagent (Magnetic cell separation system reagent, Class III, sponsor…

Intended purpose

The CliniMACS CD45RA Reagent is intended for in vitro magnetic labeling of CD45RA positive human cells to enable the depletion of human CD45RA positive cells with a CliniMACS System only.

Functional description

The CliniMACS CD45RA Reagent allows direct magnetic labeling of the CD45RA antigen and therefore of CD45RA positive cells. The CD45RA antigen is a membrane protein expressed on human naïve CD4+ and CD8+ T cells, e.g.. The magnetically labelled cell preparation is processed using a CliniMACS CD45RA Cell Separation System, resulting in the final target cell fraction, unwanted cells (magnetically labeled CD45RA+ cells) are removed.

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