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BD OneFlow™ PCD
(CE_IVD)PCD
Regulatory Status Legend
Any use of products other than the permitted use without the express written authorization of Becton, Dickinson and Company is strictly prohibited.
Description
The BD OneFlow™ PCD (Plasma Cell Disorders) tube, when run in parallel with the BD OneFlow™ PCST (Plasma Cell Screening Tube), is intended for flow-cytometric immunophenotyping of normal and aberrant plasma cells in bone marrow as an aid in the diagnosis of multiple myeloma and other plasma cell disorders. The BD OneFlow PCD tube is designed for use with a suitably equipped BD flow cytometer and software designated for in vitro diagnostic use.
Development References (15)
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Ashman LK, Cambareri A, Nguyen L, Bühring H-J. CD117 workshop panel report. In: Kishimoto T. Tadamitsu Kishimoto .. et al., ed. Leucocyte typing VI : white cell differentiation antigens : proceedings of the sixth international workshop and conference held in Kobe, Japan, 10-14 November 1996. New York: Garland Pub.; 1997:816-818.
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Centers for Disease Control. Update: universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in healthcare settings. MMWR. 1988; 37:377-388. (Biology).
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Clinical and Laboratory Standards Institute. 2005. (Biology).
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Cobbold SP, Hale G, Waldmann H. Non-lineage, LFA-1 family, and leucocyte common antigens: new and previously defined clusters. In: McMichael AJ. A.J. McMichael .. et al., ed. Leucocyte typing III : white cell differentiation antigens. Oxford New York: Oxford University Press; 1987:788-803.
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Consensus protocol for the flow cytometric immunophenotyping of hematopoietic malignancies. Rothe G, Schmitz G. Leukemia. 1996; 10:877-895. (Biology).
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Horvathova M, Gaillard JP, Liautard J, et al. Identification of novel and specific antigens of human plasma cells by mAb. In: Schlossman SF. Stuart F. Schlossman .. et al., ed. Leucocyte typing V : white cell differentiation antigens : proceedings of the fifth international workshop and conference held in Boston, USA, 3-7 November, 1993. Oxford: Oxford University Press; 1995:713-714.
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Kalina T, Flores-Montero J, van der Velden VH, et al. EuroFlow standardization of flow cytometer instrument settings and immunophenotyping protocols. Leukemia. 2012; 26:1986-2010. (Biology).
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Kobata T, Morimoto C. CD27 Workshop Panel Report. In: Kishimoto T. Tadamitsu Kishimoto .. et al., ed. Leucocyte typing VI : white cell differentiation antigens : proceedings of the sixth international workshop and conference held in Kobe, Japan, 10-14 November 1996. New York: Garland Pub.; 1997:67-69.
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Ling NR, Maclennan ICM, Mason DY.. B-cell and plasma cell antigens: new and previously defined clusters. In: McMichael AJ. A.J. McMichael .. et al., ed. Leucocyte typing III : white cell differentiation antigens. Oxford New York: Oxford University Press; 1987:302-335.
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McMichael AJ, Beverley PC, Cobbold S, et al, ed. Leucocyte Typing III. White Cell Differentiation Antigens. New York, NY: Oxford University Press; 1987:988-993.
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Nadler LM. B Cell/Leukemia Panel Workshop: summary and comments. In: Reinherz EL, Haynes BF, Nadler LM, Bernstein ID, ed. Leukocyte Typing II: Human B Lymphocytes. New York: Springer-Verlag; 1986:3-43.
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Olive D, Cerdan C, Costello R, et al. CD28 and CTLA-4 cluster report. In: Schlossman SF. Stuart F. Schlossman .. et al., ed. Leucocyte typing V : white cell differentiation antigens : proceedings of the fifth international workshop and conference held in Boston, USA, 3-7 November, 1993. Oxford: Oxford University Press; 1995:360-370.
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Tedder TF, Wagner N, Engel P. Schlossman SF, Boumsell L, Gilks W, et al, ed. Leukocyte Typing V. White Cell Differentiation Antigens. New York, NY: Oxford University Press; 1995:684-688.
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Wijdenes J, Clément C, Klein B, Dore J-M. CD138 (syndecan-1) Workshop Panel report. In: Kishimoto T. Tadamitsu Kishimoto .. et al., ed. Leucocyte typing VI : white cell differentiation antigens : proceedings of the sixth international workshop and conference held in Kobe, Japan, 10-14 November 1996. New York: Garland Pub.; 1997:249-252.
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van Dongen JJ, Lhermitte L, Böttcher S, et al. EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia. 2012; 26(9):1908-1975. (Biology). View Reference
Please refer to Support Documents for Quality Certificates
Global - Refer to manufacturer's instructions for use and related User Manuals and Technical data sheets before using this products as described
Comparisons, where applicable, are made against older BD Technology, manual methods or are general performance claims. Comparisons are not made against non-BD technologies, unless otherwise noted.
For In Vitro Diagnostic Use.
23-22942-00
Documents are subject to revision without notice. Please verify you have the correct revision of the document, and always refer back to BD's eIFU website for the latest and most up to date information.