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The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems: - BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes . - BD Multitest IMK Kit with or without BD Trucount Tubes . - BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes - BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems: - BD Multitest IMK Kit with or without BD Trucount Tubes . - BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes - BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes - BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes . - BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes . - BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes . - BD Tritest CD3/CD8/CD45 with or without Trucount Tubes . - BD Tritest CD4/CD8/CD3 with BD Trucount Tubes . For in vitro diagnostic use.

The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis. The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

COULTER TQ-Prep Workstation: Intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent System and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indication for Use: Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described in each application's Instructions for Use. For In Vitro Diagnostic Use Only. COULTER PrepPlus 2: Intended Use: The COULTER PrepPlus 2, when used in combinations with the COULTER TQ-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indications for Use: Pipetting blood, cleared Beckman Coulter IVD reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use. For In Vitro Diagnostic Use Only.

The COULTER TO-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for measurement on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II 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 / no-wash sample preparation method for flow cytometry. This is the same intended use as previously cleared for the BD FACSCanto system with BD FACSCanto clinical software. Indications for Use: - Immunophenotyping in clinical laboratories, using previously cleared IVD I 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*. - For in vitro diagnostic use. - For use with or without the BD FACS Sample Prep Assistant II.

The BD FACSCanto system with BD FACSCanto clinical software is a flow cytometry system designed for analyzing samples prepared with the lyse / no-wash method. The BD FACS Sample Prep Assistant II is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA II combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis with a flow cytometer. The SPA II pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning protocols. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.