Drug Testing for the Qualitative Immunoassay Screening of the Population of Mature Lymphocytes
Vietnam·Risk Class TTBYT Loại C·BD OneFlow™ LST·Becton Dickinson Caribe, Ltd.·Registered Nov 02, 2024- Analysis ID
- 2403165ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230413-0012
- Product Type
- BD OneFlow™ LST
- Product Code
- 658619
- Manufacturer
- Becton Dickinson Caribe, Ltd.
- Manufacturer Country
- UNITED STATES
- Product Owner
- Becton, Dickinson and Company, BD Biosciences
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN BECTON DICKINSON ASIA LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH
- Intended Use
- 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.
- Registration Date
- Nov 02, 2024
Access comprehensive regulatory information for Drug Testing for the Qualitative Immunoassay Screening of the Population of Mature Lymphocytes in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403165ĐKLH/BYT-HTTB and manufactured by Becton Dickinson Caribe, Ltd.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECTON DICKINSON ASIA LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH.
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