CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FACS™ brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software for data acquisition and analysis. See the cytometer user’s guide for instructions.
Development References (13)
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Borowitz MJ, Guenther KL, Shults KE, Stelzer GT. Immunophenotyping of acute leukemia by flow cytometric analysis, Use of CD45 and right-angle light scatter to gate on leukemic blasts in three-color analysis. Am J Clin Pathol. 1993; 100:534-540. (Biology).
-
Borowitz MJ, Shuster J, Carroll AJ, et al. Prognostic significance of fluorescence intensity of surface marker expression in childhood B-precursor acute lymphoblastic leukemia. A Pediatric Oncology Group Study. Blood. 1997; 89:3960-3966. (Biology).
-
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).
-
Clinical Applications of Flow Cytometry: Quality Assurance and Immunophenotyping of Lymphocytes: Approved Guideline. H42-A2. 2007. (Biology).
-
Clinical and Laboratory Standards Institute. 2005. (Biology).
-
Consensus protocol for the flow cytometric immunophenotyping of hematopoietic malignancies. Rothe G, Schmitz G. Leukemia. 1996; 10:877-895. (Biology).
-
Jackson A. Basic phenotyping of lymphocytes: selection and testing of reagents and interpretation of data. Clin Immunol Newslett. 1990; 10:43-55. (Biology).
-
Jackson AL, Warner NL. Rose NR, Friedman H, Fahey JL, ed. Manual of Clincial Laboratory Immunology, Third Edition. Washington DC: American Society for Microbiology; 1986:226-235.
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Krasinskas AM, Wasik MA, Kamoun M, Schretzenmair R, Moore J, Salhany KE. The usefulness of CD64, other monocyte-associated antigens, and CD45 gating in the subclassification of acute myeloid leukemias with monocytic differentiation. Am J Clin Pathol. 1998; 110(6):797-805. (Biology).
-
Lacombe F, Durrieu F, Briais A, et al. Flow cytometry CD45 gating for immunophenotyping of acute myeloid leukemia. Leukemia. 1997; 11:1878-1886. (Biology).
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Schwinzer R. Cluster Report: CD45/CD45R. In: Knapp W. W. Knapp .. et al., ed. Leucocyte typing IV : white cell differentiation antigens. Oxford New York: Oxford University Press; 1989:628-634.
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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).
-
Stewart CC, Behm FG, Carey JL, et al. US-Canadian consensus recommendations on the immunophenotypic analysis of hematologic neoplasia by flow cytometry: selection of antibody combinations. Cytometry. 1997; 30:231-235. (Biology).
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.
