The DuraClone 34845 Reagent Kit is a four color immunofluorescence stain for the identification and enumeration of helper/inducer (CD4+) cytotoxic/suppressor (CD8+) and total T-lymphocytes (CD3+) combined with a precise number of fluorescent counting beads for absolute CD3+, CD4+, CD8+, T-Cells and absolute lymphocyte counts. This reagent is intended for flow cytometry based analysis in lysed human whole blood samples.
The reagent contains fluorescently labeled antibodies that bind to CD45, CD3, CD4 and CD8 antigens found on the surface of circulating leukocytes. The CD3 antigen is a complex of at least six proteins, known collectively as the T-cell receptor (TCR) complex. The antibody used in this reagent binds to the 20 kDa ε chain of this complex. The CD4 antigen is a 59 kDa protein which interacts with class II molecules of the major histocompatibility complex and is the primary receptor for the Human Immunodeficiency Virus (HIV). The CD8 antigen is a complex consisting of two disulfide linked subunits. The antibody used in this reagent binds to the 32 kDa α subunit of the complex. CD8 interacts with class I major histocompatibility complex molecules. The CD45 antigen is a complex 180-220 kDa transmembrane glycoprotein which is expressed in high levels on leukocyte cell surfaces and its presence distinguishes leukocytes from non-haematopoietic cells.
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The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
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RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
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No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.