Device Dossier

CliniMACS TCRα/β-Biotin - Magnetic cell separation system reagent

Device Dossier for CliniMACS TCRα/β-Biotin - Magnetic cell separation system reagent (Magnetic cell separation system reagent, Class III, sponsor…

Intended purpose

The CliniMACS TCRa/ß-Biotin is intended for the in vitro labeling of TCRa/ß positive human cells with biotinylated antibodies to enable depletion of TCRa/ß positive human cells in combination with a CliniMACS System only.

Functional description

The CliniMACS TCRα/β-Biotin allows direct biotin labeling of the TCRα/β positive cells. Then, the biotin labeled cells are magnetically labeled with CliniMACS Anti-Biotin Reagent. The TCRα/β antigen is a membrane protein expressed on a human sub-population of T cells, e.g.. The magnetically labeled cell preparation is processed using a CliniMACS TCRα/β Cell Separation System, resulting in the final target cell fraction, unwanted cells (magnetically labeled TCRα/β+ cells) are removed.

TGA Public Summary