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Stem-Kit Reagents is intended for the simultaneous identification and enumeration of CD45+ and dual-positive CD45+ CD34+ cell population percentages and absolute counts in biological specimens by flow cytometry. Biological specimens include fresh normal or mobilized peripheral whole blood, and fresh or thawed apheresis products, cord blood and bone marrow. Cell population measurements may be obtained using either an automated method or a manual method for gating and analysis.
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NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
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."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.
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