Device Dossier

CliniMACS CD19 Reagent - Magnetic cell separation system reagent

Device Dossier for CliniMACS CD19 Reagent - Magnetic cell separation system reagent (Magnetic cell separation system reagent, Class III, sponsor Miltenyi…

Intended purpose

The CliniMACS CD19 Reagent is intended for/'n vitro magnetic labeling of CD 19 positive human cells to enable the depletion of human CD19 positive cells with a CliniMACS System only.

Functional description

The CliniMACS CD19 Reagent allows direct magnetic labeling of the CD19 antigen and therefore of CD19 positive cells. The CD19 antigen is a membrane protein expressed on all human B cells, e.g.. The magnetically labeled cell preparation is processed using a CliniMACS CD19 Cell Separation System, resulting in the final target cell fraction, unwanted cells (magnetically labeled CD19+ cells) are removed.

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