The population cross-reactive immunodiffusion qualitative test kit - Vietnam Registration 2403586ĐKLH/BYT-HTTB

BD OneFlow™ Plasma Cell Disorders Panel is used for in vitro diagnostic qualitative assessment of the immunophenotype of the plasma cell population by flow cytometry on the BD Flow Cytometry Instrument, equipped with: • A 488-nm blue laser, a 640-nm red laser, and a 405-nm violet laser • Ability to detect forward scatter (FSC) and side scatter (SSC) • At least eight fluorescent colors • Software for data collection and analysis. BD OneFlow™ Plasma Cell Disorders Panel is used to support the differential diagnosis of patients with, or suspected of having, plasma cell disorders. BD OneFlow™ Plasma Cell Disorders Panel can be used with bone marrow samples collected in EDTA or heparin tubes. Results must be interpreted by a medical laboratory or equivalent expert in combination with clinical findings or other tests. BD OneFlow™ Plasma Cell Disorders Panel includes the following BD OneFlow™ tubes: • BD OneFlow™ PCST (Plasma Cell Screening Tube) for qualitative assessment of the immunophenotype of the plasma cell population. • BD OneFlow™ PCD (Plasma Cell Disorders Tube) for qualitative assessment of the immunophenotype of plasma cell disorders. The qualitative, multi-parameter results for the antigens listed below are provided by the BD OneFlow™ PCDP tubes: The specific antigens of the BD OneFlow™ PCDP tubes: -BD OneFlow™ PCST (Plasma Cell Screening Tube) contains fluorescently labeled monoclonal antibodies to bind to antigens including: CD38 labeled with FITC, CD56 labeled with PE, β2-microglobulin labeled with PerCP-Cy5.5, CD19 labeled with PE-Cy7, cylgk (b) labeled with APC, cyIgλ labeled with APC-H7, CD45 labeled with V450 (a) and CD138 labeled with V500-C (a) -BD OneFlow™ PCD (Plasma Cell Disorders Tube) contains fluorescently labeled monoclonal antibodies to bind to antigens including: CD38 labeled with FITC, CD28 labeled with PE, CD27 labeled with PerCP-Cy5.5, CD19 labeled with PE-Cy7, CD117 labeled with APC, CD81 labeled with APC-H7, CD45 labeled with V450 (a) and CD138 labeled with V500-C (a). Where: (a) BD Horizon™ V450, BD Horizon™ V500-C, (b) cy refers to the cytoplasm.