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U.S. Department of Health and Human Services

Product Classification

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Device whole blood pre-treatment t-cell enrichment reagent
Definition The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C).
Physical State Liquid reagent
Technical Method The reagent contains bispecific monoclonal antibodies which are directed against cell surface markers on selected white blood cells and glycophorin A on red blood cells. The reagent cross-links the selected white blood cells with the red blood cells, which increases the density of the selected cells. When a density gradient is applied during the blood cell extraction process, the selected white blood cells remain separated into the red blood cell layer away from the PBMC layer and non-selected cells, including T cells and antigen presenting cells contained in the PBMC layer.
Target Area Whole blood samples
Review Panel Microbiology
Product CodeORL
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible