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The BD FACSCanto flow cytometer (4-3-3 configuration) functions as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (640 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. For in vitro diagnostic use. The BD FACSCanto II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. For in vitro diagnostic use.

The BD FACSCanto and FACSCanto II (BD FACSCanto II 4-2-2, BD FACSCanto II 5-3 and BD FACSCanto 4-3-3 configurations) are comprised of a flow cytometer, a fluidics cart, and a computer workstation. The flow cytometer acquires and analyzes the sample, the fluidics cart contains operational fluids, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping assays prepared using the lyse/wash or lyse/no-wash methods, and BD FACSDiva software for installation, service, and manual user-validated applications. The BD FACSCanto and FACSCanto II systems can optionally be used with the BD FACSLoader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software and BD FACSDiva software, and/or the BD FACS Sample Prep Assistant III for automatic sample preparation of assays utilizing the lyse/no-wash method.

BD Multitest™ 6-color TBNK reagent with optional BD Trucount™ tubes is a sixcolor direct immunofluorescence reagent for use with BD FACSCanto™ and BD FACSCanto™ II flow cytometers to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood. BD Multitest 6-color TBNK reagent and BD Trucount tubes can be used with the BD FACS™ Loader.

Human lymphocytes can be divided into three major subset populations based on their biologic function and cell-surface antigen expression: T Ivmphocytes (CD3+), B lymphocytes (CD19+), and Natural Killer (NK) cells (CD16+ and/or CD56+). CD3+ T lymphocytes can be further divided into CD4+ T lymphocytes and CD8+ T lymphocytes. BD Multitest 6-Color TBNK Reagent is a monoclonal antibody cocktail of CD3-FITC/ CD16-PE + CD56-PE/ CD45-PerCP-Cy5.5/ CD4-PE-Cy7/ CD19-APC/ CD8-APC-Cy7. When the reagent is used to stain a known volume of whole blood, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS™ Lysing Solution to lyse erythrocytes prior to acquisition and analysis on the BD FACSCanto or BD FACSCanto II flow cytometer. During acquisition, the cells travel past two spatially separated laser beams. The cells scatter the laser light and the cell-bound fluorochrome-labeled antibodies fluoresce. These scatter and fluorescence signals are detected by the flow cytometer and provide information about the cell's relative size, internal complexity and fluorescence intensity. During analysis by BD FACSCanto clinical software, the lymphocyte population percentages are determined. Lymphocyte population absolute counts may be determined if Ivmphocvte data from another method is manually entered.

BD FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

BD FACSCount CD4 reagents are intended for use in enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood using the BD FACSCount instrument system. The product offers a single test that requires one convenient, ready-to-use reagent tube labeled CD4. It is intended for use on a BD FACSCount instrument. The reagent kit consists of the following components: 50 reagent tubes of CD4 PE/CD14 PE-Cy5/CD15 PE-Cy5/fluorescent nuclear dye and counting reference beads, 65 reagent tube caps, One 5-mL vial of 5% formaldehyde in phosphate-buffered saline (PBS), used as fixative solution.

The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/uL. For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510-545 nm, 562-607 nm, and >650 nm. For use in erythrocyte-lysed whole peripheral blood. For use with or without isotype control. To characterize and monitor some forms of autoimmune disease. To characterize and monitor some forms of immunodeficiency disease, such as in HIV- infected individuals.

The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/μL. If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™, CELLQuest Pro™ or LYSYS™ II software. The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes vields 50 tests.

BD Tritest CD3 FITC/CD4 PE/CD45 PerCP is a three-color direct immunofluorescence reagent for identifying and enumerating percentage of mature human T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB).

The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™ , CELLQuest Pro "" or LYSYS™ II software. The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes yields 50 tests.

Immunophenotyping in clinical laboratories, using previously cleared in vitro . diagnostic assays for flow cytometry. Identification and enumeration of lymphocyte subsets in human cells in . suspension. For in vitro diagnostic use. . For use with or without the BD FACS Sample Prep Assistant II. .

The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer workstation. The fluidics cart contains operational fluids, the flow cytometer acquires and analyzes the sample, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping of assays prepared using the lyse/no-wash method, and BD FACSDiva software for manual immunophenotyping of assays prepared using the lyse/wash method. The BD FACSCanto II system can optionally be used with the BD FACS Loader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software, and with the BD FACS Sample Prep Assistant II for automatic sample preparation of assays utilizing the lyse/no-wash method. The BD FACSCanto II system is a modification of the BD FACSCanto system, bearing the same intended use, indications for use, and operating principle as its predicate device. Modifications have been made to the fluidics, optics, and electronics subsystems. Changes were also made to the sample introduction system, the BD FACS Loader option, and to the two software applications. These changes have been made to enhance the system's usability.

BD Multitest 6-Color TBNK reagent with BD Trucount tubes is intended for in vitro diagnostic use with the BD FACSCanto system to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.

The BD Multitest 6-Color TBNK reagent is a six-color direct immunofluorescence reagent for use with the BD FACSCanto system to identify and determine the percentages and absolute counts (using BD Trucount tubes) of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood. When a known volume of whole blood is added to the reagent in a BD Trucount tube, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS lysing solution to lyse erythrocytes, and the lyophilized pellet in the BD Trucount tube dissolves, releasing a known number of fluorescent beads. During acquisition, the cells and beads travel past two laser beams and scatter the laser light. The stained cells and beads fluoresce at different intensities. These scatter and fluorescence signals, detected by the flow cytometer, provide information about each cell's size, internal complexity, and relative fluorescence intensity. During analysis, the absolute number (cells/uL) of positive cells in the sample can be determined by comparing cellular events to bead events.

The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device for identification and cnumeration of lymphocyte subsets in human cells in suspension using a lyse no-wash sample preparation method for flow cytometry. Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method. Immunophenotyping of lymphocyte subsets including CD3*CD8*, . CD3*CD4*, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*

The BD FACSCanto System with BD FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. The fluidics cart contains operational fluids, the flow cytometer acquires and analyzes the sample, and the computer displays and prints the analysis. The flow cytometer utilizes three sub-systems; fluidics, optics and electronics. It contains two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.