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The beads are for use on a BD FACSCanto™ flow cytometer equipped with BD FACSCanto software. The beads are used to adjust detector voltages, to set fluorescence compensation and to monitor daily instrument performance. For In Vitro Diagnostic Use.

BD FACS 7-color setup beads are intended for use on the BD FACSCanto flow cytometer equipped with a 488-nm blue laser, a 633-nm red laser, and six fluorescence detectors. BD FACS 7-color setup beads are provided as a lyophilized pellet contained in 25 individually packaged test tubes along with a bottle of BD FACS setup bead diluent.

The BD FACSCanto System with BD FACSDiva software is intended for use as an In Vitro Diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse wash sample preparation method for flow cytometry. Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse 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 FACSDiva software is comprised of a flow cytometer, a wet cart, and a computer. The wet 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 one software package for manual immunophenotyping and is compatible with the BD FACSLoader for automatic sample introduction.

MultiTEST CD3/CD16+56/CD45/CD19 and MultiTEST IMK kit - For use with Becton Dickinson FAC® flow cytometers equipped with a blue (488-nm) and red diode (635-nm) laser. - Monoclonal antibody reagents for identification and enumeration of mature human lymphocyte subsets in peripheral blood of normal individuals and patients with certain immune dysfunction. - MultiTEST CD3/CD16+56/CD45/CD19 provides percentages and absolute counts of T (CD3'), NK(CD3 CD16'CD56'), and B (CD3'CD19') lymphocytes. - MultiTEST CD3/CD8/CD45/CD4 provides percentages and absolute counts of T (CD3*), helper/inducer T (CD3*CD4*) and suppressor/cytotoxic T (CD3*CD8*) lymphocytes. - For use with erythrocyte lysed whole blood without an isotype control. - To characterize and monitor forms of auto immune diseases, such as lupus. - To characterize and monitor congenital or acquired immunodeficiences, such as SCID or AIDS. - For in vitro diagnostic use

The Becton Dickinson CD3 fluorescein isothiocyanate (FITC)/CD16+56 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP)/CD19 allophycocyanin (APC) reagent is a four-color, direct immunofluorescence reagent for identifying and enumerating percentages and absolute counts of CD3+ T lymphocytes, CD3-CD16+56+ natural killer (NK), and CD3-CD19+ B lymphocyte subsets in erythrocyte-lysed whole blood. Each vial of reagent yields 50 tests. The reagent is intended for use on the Becton Dickinson FACSort™ or FACSCalibur™ flow cytometers equipped with the FL4 Option, the Apple® Macintosh® Quadra or PowerPC computer, and CELLQuest™ or MultiSET™ software. Daily instrument set-up requires CaliBRITE™ beads (unlabeled, FITC, PE, PerCP, and APC) and FACSComp™ software. The four-color method permits the identification and enumeration of T, NK, and B lymphocyte subsets using MultiSET software's expert lymphocyte gate and automated single-tube quality control algorithms. A lymphocyte gate is drawn for the CD45 * leucocytes with low side scatter and the lymphocyte subsets are provided as an absolute count or percentage of total lymphocytes.

For the FACS® family of flow cytometers equipped with a blue (488-nm) and a red t diode (635-nm) laser. A monoclonal antibody reagent for identification and enumeration of mature human T . lymphocyte subsers in human peripheral blood. For use with crythrocyte lysed whole blood. . To characterize and monitor forms of autoimmune diseases, such as lupus. . To characterize and monitof congenital or acquired immunodeficiencies, such as . SCID or AIDS. For in vitro diagnostic use.

The Becton Dickinson CD3 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP)/CD4 allophycocyanin (APC) reagent is a four-color, direct immunofluorescence reagent for identifying and enumerating percentages of CD3+ T Lymphocytes, CD3+CD4+ helper/inducer, and CD3+CD8+ suppresser/cyroroxic T-Lymphocyte subscts in erythrocyce-lysed whole blood. Each vial of reagent yields 50 tests. The reagent is intended for use on the Becton Dickinson FACSCalibur 10 flow cycomerers equipped with the FL4 Option, the Apple Macintosh Quadra or PowerPC computer, and CELLQuest or MultiSET software. Daily instrument set-up requires CaliBRITE beads (unlabeled, FITC, PE, Per CP, and APC) and FACSComp software.

For flow cytometer set up and monitoring of instrument performance prior to performing reticulocyte ennumeration or immunophenotyping applications. Flow cytometry has been found useful in monitoring some forms of immune disease. For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur). An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping. For adjusting instrument settings: aligning the signal from the blue and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time. For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals. For monitoring the sensitivity of the side scatter (SSC) and fluorescence (FLI, FL2, FL3, and FL4) detectors and verifying adequate separation of system noise from forward scatter (FSC) signals. For in vitro diagnostic use.

Becton Dickinson FACSComp software and the CaliBRITE 4 bead kir (FACSComp/CaliBRITE 4) are intended for use on the Becton Dickinson flow cytometers, FACSort™ or FACSCalibur™, equipped with the FL4 Option. FACSComp/CaliBRITE 4 are used to check laser alignment, optimally adjust instrument settings, monitor sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp/CaliBRITE 4 are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with four fluorescence (FL) channels FACSComp/CaliBRITE 4 is used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on flow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. The CaliBRITE beads are provided as a separate vial of CaliBRITE APC beads and the four-vial CaliBRITE 3 kit, comprised of unstained, FITC-, PE- and PerCP-labeled beads.

For in vitro diagnostic use to identify and enumerate absolute counts of T lymphocyte (CD3+), helper/inducer T lymphocyte (CD3+CD4+) and suppressor/cytotoxic T lymphocyte (CD3+CD8+) subsets in blood. - For use with any flow cytometer equipped with a 488 nm last and capable of detection in . the ranges: 515-545 nm, 562-607 nm, and >650 nm - For use with erythrocyte lysed whole blood . - For in vitro diagnostic use . - To identify and enumerate absolute counts of CD3+ and CD3+CD4+ and CD3+CD8+ . lymphocytes - To characterize and monitor some forms of immunodeficiency, such as in HIV infected . individuals - To characterize and monitor some forms of autoimmune diseases .

The BDIS TriTEST CD4 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD3 peridinin chlorophyll protein (PerCP) reagent is a three-color, direct immunofluorescence reagent. When used with TRUCOUNT Absolute Count Tubes it is used for identifying and enumerating absolute counts of I lymphocytes (CD3+), helper/inducer T lymphocytes (CD3+CD4+) and suppressor/cytotoxic I lymphocytes (CD3+CD8+) in erythrocyte-lysed whole blood (LWB). The Becton Dickinson TnTEST / TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (Tril EST CD4 FITC/CD8 PE/CD3 PeCP) and TRUCOUNT Absolute Count Tubes. The process to obtain T lymphocyte subset absolute counts includes: 1) obtaining a whole blood sample, 2) adding a precise volume of whole blood directly to the Absolute Count Tube, 3) cell-surface antigen staining with three-color monoclonal antibody reagents, 4) erythrocyte lysis, and 5) flow cytometric acquisition and analysis of list mode data. Analysis for absolute counts requires that the bead region be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is I x (beads/pellet)/(volume of blood sample).

For in vitro diagnostic use to identify and enumerate percentages and absolute counts of T and NK lymphocytes in blood. For use with any flow cytometer with specified detection ranges. For use with erythrocyte lysed whole blood. For use with or without an isotype control. For in vitro diagnostic use. To identify and enumerate percentages and absolute counts of CD3+ and CD16+CD56+ lymphocytes in normal individuals and patients with certain tumors and viral infections

The BDIS TriTEST CD3 fluorescein isothiocyanate (FITC)/CD16+CD56 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Natural Killer lymphocytes (CD3- and CD16+ and/or CD56+) in erythrocytelysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/uL. The Becton Dickinson TriTEST/TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (TriTEST CD3 FITC/CD16+CD56 PE/CD45 PerCP) and TRUCOUNT Absolute Count Tubes. The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow cytometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events to the CD45 positive events, and expressing the ratio as a percentage. To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, the bead region, be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is P x (beads/pellet)/(volume of blood sample). When monoclonal antibody reagents are added to human whole blood, the fluorochromelabeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam. The three-color reagent permits identification of lymphocyte subsets using fluorescence gating instead of scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gating on the CD45-positive population, a maximum number of lymphocytes may be captured in the gate and non-lymphocyte contamination may be minimized.

For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD4+ lymphocytes in blood. For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 515-545 nm, 562-607 nm, and > 650 nm. For use with erythrocyte-lysed peripheral whole blood. For use with or without an 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 BDIS TriTEST CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and T-helper (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/UL. The Becton Dickinson TriTEST/TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacture), conjugated monoclonal reagent (TriTEST CD3 FITC/CD4 PE/CD45 PerCP) and TRUCOUNT Absolute Count Tubes. The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow cytometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events (CD3+CD4+) to the CD45 positive events, and expressing the ratio as a percentage. To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is P x (beads/pellet)/(volume of blood sample). When monoclonal antibody reagents are added to human whole blood, the fluorochrome-labeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam. The three-color reagent permits identification of lymphocyte subsets using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gating on the CD45-positive population, a maximum number of lymphocytes may be captured in the gate and non-lymphocyte contamination may be minimized.

For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD8+ lymphocytes in blood. For use with any flow cytometer equipped with a 488 mm laser and capable of detection in the ranges: 515-545 nm, 562-607 nm, and > 650 nm. For use with erythrocyte lysed whole blood. For use with or without an isotype control. To characterize and monitor forms of autoimmune diseases, such as lupus. To characterize and monitor congenital or acquired immunodeficiencies, such as SCID or AIDS.

The BDIS Trilles T CD3 flucescein isothiocyanate (FITC)/CD8 phycocrythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunoflucrescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Tsuppressor/cytotoxic (CD3+CD8+) cells in eythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/JL. The Becon Dickinson Trill BT/TRUCOUNT system for immunophenoryping consists of a flow cycometer (either from BDIS or from another manufacture), conjugated monoclonal reagent (TriTEST CD3 FITC/CD8 PE/CD45 PerCP) and TRICOUNT Absolute Count Tubes. The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow crometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events to the CD45 positive events, and expressing the ratio as a percentage. To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, the bead region, be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is I x (beads/pellet)/(volume of blood sample). When monoclonal antibody reagents are added to human whole blood, the flucrochrome-labeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluctochrome-labeled antibodies and the crythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excired by a laser beam. The three-color reagent permits identification of lymphocyte subsers using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45positive population using a combination of fluorescence and side scatter parameters. By gaing on the CD45-positive population, a maximum number of lymphocyces may be caprured in the gate and non-lymphocyte contamination may be minimized.

For in vitro diagnostic use to identify and enumerate percentages and absolute counts of T and B lymphocytes in bload. Indications for Use - For use with any flow cytometer with specified detection ranges . - For use with erythrocyte lysed whole blood . - For use with or without an isotype control . - For in vitro diagnostic use . - To identify and enumerate percentages and absolute counts of CD3+ and CD19+ ● lymphocytes - To characterize and monitor some forms of immunodeficiency . - To characterize and monitor some forms of autoimmune diseases .

The BDIS TriTEST CD3 fluorescein isothiocyanate (FITC)/CD19 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and B lymphocytes (CD19+) in eythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/uL. The Becton Dickinson Tril EST / TRUCOUNT system for immunophenotyping consists of a flow cytometer (cither from BDIS or from another manufacturer), conjugated monoclonal reagent (TriTEST CD3 FITC/CD19 PE/CD45 PeCP) and TRUCOUNT Absolute Count Tubes. The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow cytometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events (CD3+ and CD19+) to the CD45 positive events, and expressing the ratio as a percentage. To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, the bead region, be identified and the events in this region counted. The proportion of reagent positive events to be identified and are trated. The absolute count is P x (beads/pellet)/(volume of blood sample). When monoclonal antibody reagents are added to human whole blood, the fluorochromelabeled antibodies bind specifically to antigens on the surface of leucocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead peller and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam. The three-color reagent permits identification of lymphocyte subsets using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gating on the CD45-positive population, a maximum number of lymphocytes may be captured in the gate and non-lymphocyte contamination may be minimized.