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ClearLLab Antibody Solutions
Beckman Coulter is revolutionizing the leukemia and lymphoma analysis in clinical flow cytometry laboratories with the innovative ClearLLab Solutions:
ClearLLab 10C system is an integrated FDA cleared and CE-marked IVD leukemia and lymphoma*(L&L) immunophenotyping solution for lymphoid and myeloid lineages using the dry
DURA Innovations technology ClearLLab Control Cells are the first application specific control cells for L&L immunophenotyping
ClearLLab Reagents are the first 5-color panels to receive US Food and Drug Administration (FDA) clearance (via the De Novo Process) for L&L flow cytometric immunophenotyping in the clinical lab.
*For Non-Hodgkin’s lymphoma only
Beckman Coulter, Inc. All rights reserved.
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.