ClearLLab Control Cells Normal, 25 Tests, CE, IVD
ClearLLab Control Cells Normal and ClearLLab Control Cells Abnormal are stabilized preparations of assayed, lysable whole blood intended as process controls for the verification of the ClearLLab 10C Panels on the Navios and Navios EX flow cytometers.
Parameters assayed include: Kappa, Lambda, CD5, CD200, CD38, CD20, CD19, CD45, TCRγδ, CD4, CD2, CD56, CD3, CD7, CD8, CD16, CD10, CD13, CD64, CD14, HLA-DR, CD11b, CD15, CD33, CD34, CD117, and CD123
They provide positive cell controls that are processed in the same manner as a whole blood sample. This allows verification of reagent performance and the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples with flow cytometry.
|Regulatory Status||CE, IVD|
|Flow Product Line||ClearLLab|
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.