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BD OneFlow™ B-CLPD T1
(CE_IVD)B-CLPD T1
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™ B-CLPD T1 (B-cell Chronic Lymphoproliferative Diseases Tube 1) shall be used for specimens with B-lineage populations needing further investigation in combination with the BD OneFlow™ LST (Lymphoid Screening Tube). The BD OneFlow B-CLPD T1 is intended for flow-cytometric immunophenotyping of B cells in peripheral blood and bone marrow as an aid in the diagnosis of chronic lymphocytic leukemia (CLL) and other B-cell chronic lymphoproliferative diseases. The BD OneFlow B-CLPD T1 is designed for use with a suitably equipped BD flow cytometer and software designated for in vitro diagnostic use.
Development References (21)
-
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).
-
Cerný J, Angelisová P, Horejší V. Mason D, André P, Bensussan A, et al, ed. Leucocyte Typing VII: White Cell Differentiation Antigens. New York, NY: Oxford University Press; 2002:458.
-
Clinical and Laboratory Standards Institute. 2007. (Biology).
-
Clinical and Laboratory Standards Institute. 2014. (Biology).
-
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.
-
Consensus protocol for the flow cytometric immunophenotyping of hematopoietic malignancies. Rothe G, Schmitz G. Leukemia. 1996; 10:877-895. (Biology).
-
Davis BH, Dasgupta A, Kussick S, Han JY, Estrellado A; on behalf of ICSH/ICCS working group. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - Part II - Preanalytical issues. Cytometry Part B. 2013; 84B:286-290. (Biology).
-
Dörken B, Möller P, Pezzutto A, Schwartz-Albiez R, Moldenhauer G. Knapp W, Dörken B, Gilks WR, et al, ed. Leucocyte Typing IV: White Cell Differentiation Antigens. New York, NY: Oxford University Press; 1989:33-34.
-
Engel P, Wagner N, Tedder TF. Schlossman SF, Boumsell L, Gilks W, et al, ed. Leucocyte Typing V: White Cell Differentiation Antigens. New York, NY: Oxford University Press; 1995:667-679.
-
Hilgert I, Drbal K. Mason D, André P, Bensussan A, et al, ed. Leucocyte Typing VII: White Cell Differentiation Antigens. New York, NY: Oxford University Press; 2002:459-461.
-
Horejsi V, Stockinger H. CD43 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.; 1997:494-497.
-
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).
-
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.
-
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.
-
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.
-
Nicholson JKA, Green TA. Selection of anticoagulants for lymphocyte immunophenotyping: effect of specimen age on results. J Immunol Methods. 1993; 165:31-35. (Biology).
-
Paxton H, Bendele T. Effect of time, temperature, and anticoagulant on flow cytometry and hematological values. Ann NY Acad Sci. 1993; 677:440-443. (Biology).
-
Sarfati M, Ishihara H, Delespesse G. CD23 Workshop Panel 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; 1995:530-533.
-
Stelzer GT, Marti G, Hurley A, McCoy PJ, Lovett EJ, Schwartz A. US-Canadian consensus recommendations on the immunophenotypic analysis of hematologic neoplasia by flow cytometry: standardization and validation of laboratory procedures. Cytometry. 1997; 30:214-230. (Biology).
-
Stetler-Stevenson M, Greig B, Yuan C. Kottke-Marchant K, Davis BH, ed. Laboratory Hematology Practice 1st edition. Hoboken, NJ: Wiley-Blackwell Inc; 2012:105-114.
-
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.