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BD FACSPresto System: The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. · For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings. · For use in children, adolescents, and adults. · For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes. · Not for point-of-care use. · For in vitro diagnostic use. BD FACSPresto CD4/Hb Cartridge & BD FACSPresto CD4/Hb Cartridge Kit: The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings. · For use in children, adolescents, and adults · For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes. · Not for point-of-care use. · For in vitro diagnostic use. BD Multi-Check Control: The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BDTM Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. BD Multi-Check CD4 Low Control: The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and data analysis. The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. Eurotrol FACSPresto Hb Control: Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPrestoTM System.

The BD FACSPresto System is an accurate, robust, and portable CD4, %CD4, and hemoglobin (Hb) System. The BD FACSPresto System has fluorescence microscopy and light absorbance capabilities. In addition, the instrument has integrated BD FACSPresto Software and instrument quality controls. The BD FACSPresto CD4/Hb Cartridge contains antibody-fluorophore conjugates dried on a reagent disc and is embedded with reagent quality controls. The cartridge is designed with onboard reagents that mix well into the blood sample, and enumerate cells populations using fluorescence only. The cartridge is designed with fluidic properties that distribute a sufficient volume and sample into the imaging field of view for precise cell counting. The BD FACSPresto CD4 and %CD4 assays are designed to stain cells with antibody-fluorophore conjugates for three color fluorescence reading using the BD FACSPresto System. CD4 PE-Cy5 stains CD4-positive cells; while CD3-APC and CD45RA-APC stains total lymphocytes for use in the %CD4 calculation (CD3 stains T cells, while CD45RA stains B and NK cells in a patented formulation). CD14-PE is used for staining monocytes to exclude CD4 and/or CD45RA expressing monocytes from analysis. BD Multi-Check Control and BD Multi-Check CD4 Low Control are process controls for the CD4 and %CD4 assay on the BD FACSPresto system. They are composed of human leukocytes and erythrocytes in a stabilizing medium and are intended to be used as a complete process control for antibody staining. instrument performance, and data analysis on the BD FACSPresto system. The BD FACSPresto Hb assay is performed by a spectrophotometric method. using absorbance at an isobestic point for multiple forms of hemoglobin, with correction for scatter. The cartridge microfluidic channel permits absorbance reading of blood and of a reference area. Eurotrol FACSPresto Hb Control is used as a process control for the Hb assay on the BD FACSPresto system. It is composed of purified bovine hemolysate and is intended to be used as an assayed hemoglobin process control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto System.