The ClearLLab reagents are intended for in vitro diagnostic use as a screening panel for identification of various cell populations by immunophenotyping on an FC 500 flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having hematopoietic neoplasia including 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, ACD or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens for immunophenotyping. The results should be interpreted along with additional clinical and laboratory findings. These reagents provide qualitative results for the parameters listed below:
ClearLLab T1: CD2, CD56, CD7, CD5, CD45
ClearLLab T2: CD8, CD4, CD3, CD45
ClearLLab B1: Kappa, Lambda, CD19, CD5, CD45
ClearLLab B2: CD20, CD10, CD19, CD38, CD45
ClearLLab M: CD7, CD13, CD34, CD33, CD45
￮ CE marked: Minimize your lab’s validation work.
￮ Enhanced workflow: No manual antibody cocktail preparation.
￮ Consensus aligned: Ensures you work according to international guidelines.
￮ Small kit size: Adapt your inventory to actual demand with the 25 tests/vial.
￮ Versatile: ClearLLab can be used with peripheral blood, bone marrow and lymph node specimens.
￮ Identify major cell populations with ClearLLab’s 5-combination, 18-marker panels.
ClearLLab T1 CD2-FITC/CD56-PE/CD7-ECD/CD5-PC5.5/CD45-PC7 The antigen specificity of the CD45, CD2, CD56, CD7, and CD5 monoclonal antibodies comprising the ClearLLab T-cell Tube 1 reagent has been previously established by the Second (CD2 and CD7), Third (CD5 and CD45), Fourth (CD56) International Workshop for Leukocyte Typing.
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.