Device Dossier

CliniMACS Anti-Biotin Reagent - Magnetic cell separation system reagent

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

Intended purpose

The CliniMACS Anti-Biotin Reagent is intended for the in vitro magnetic labeling of human cells previously labeled with biotinylated antibodies to enable enrichment or depletion of human cells in combination with a CliniMACS System only.

Functional description

The CliniMACS Anti-Biotin Reagent allows direct magnetic labeling of human target cells previously labeled with biotinylated antibodies or ligands. It specifically binds the biotin molecules conjugated to a primary antibody or ligands, which is specific for a certain cell-surface antigen. The magnetically labeled cell preparation is processed using a CliniMACS Anti-Biotin Cell Separation System, resulting in the final target cell fraction, unwanted cells are remov

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