Drug Testing for the Qualitative Immunoassay Screening of the Population of Mature Lymphocytes - Vietnam Registration 2403165ĐKLH/BYT-HTTB

BD OneFlow™ Lymphoid Screening Tube (BD OneFlow™ LST) for chronic lymphocytic proliferation disorders (CLPD) is used for in vitro diagnosis as a panel of fluorescently labeled antibodies to quantitate the phenotype of the population of mature lymphocytes by flow cytometry on a 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™ LST is used to support the differential diagnosis of patients with abnormal blood counts, who have, or are suspected of having, CLPD of B cells, CLPD of T cells, and CLPD of NK cells. These tubes can be used with peripheral blood and bone marrow samples collected in EDTA or heparin tubes and with lymph node biopsy specimens. The results must be interpreted by a hematologist or equivalent expert in combination with clinical findings or other tests. BD OneFlow™ LST contains fluorescently labeled monoclonal antibodies that bind to antigens including: CD8 and Igλ labeled with FITC, CD56 and Igκ labeled with PE, CD5 labeled with PerCP-Cy5.5, CD19 and TCRγ/δ labeled with PE-Cy7, CD3 labeled with APC, CD38 labeled with APC-H7, CD20 and CD4 labeled with V450, and CD45 labeled with V500-C.