ClearLLab 10C B Cell Tube, 25 Tests, CE, IVD
The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios and Navios EX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
These reagents provide multiparameter, qualitative results for the surface antigens listed below:
- ClearLLab 10C B Cell Tube:Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45
- ClearLLab 10C T Cell Tube: TCRγδ, CD4, CD2, CD56, CD5, CD34, CD7, CD8, CD3, CD45
- ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45
- ClearLLab 10C M2 Cell Tube:CD15, CD123, CD117, CD13, CD33, CD34, CD38, HLA-DR, CD19, CD45
|Specificity||κ Chain, λ Chain, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45|
|Fluorochrome||FITC, PE, ECD, PC5.5, PC7, APC, APC-Alexa Fluor* 700, APC-Alexa Fluor* 750, Pacific Blue*, Krome Orange|
|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.