The LeukoSure Enumeration Kit is comprised of a set of reagents used to prepare and enumerate white blood cells in leukoreduced red blood cell and platelet products by flow cytometry. Leukosure Fluorospheres consists of 10 ┬Ám (nominal diameter) dye-containing polystyrene fluorospheres in an aqueous suspension medium containing a surfactant, and 1% formaldehyde. The assayed concentration of LeukoSure Fluorospheres is derived from multiple replicate analyses on a Z1/Z2 COULTER COUNTER┬«.

Specifications

Format Liquid
Size 200 Tests
Regulatory Status CE, IVD
UNSPSC 41116015

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.