ClearLLab Antibody Solutions

Beckman Coulter is revolutionizing the leukemia and lymphoma analysis in clinical flow cytometry laboratories with the innovative ClearLLab Solutions:

  • ClearLLab Reagents are the first reagents to receive US Food and Drug Administration (FDA) clearance (via the De Novo Process) for leukemia and lymphoma* flow cytometric immunophenotyping in the clinical lab.
  • ClearLLab Reagents are comprised of five pre-formulated antibody cocktails targeted at B-, T-, and Myeloid cell malignancies, significantly reducing validation time thanks to IVD status 
  • ClearLLab Antibody solutions are compatible with current Clinical Guidelines

*For Non-Hodgkin’s lymphoma only

ClearLLab Reagents

ClearLLab Reagents are the first reagents to receive US Food and Drug Administration (FDA) clearance (via the De Novo Process) for leukemia and lymphoma* flow cytometric immunophenotyping in the clinical lab.  They are comprised of five pre-formulated antibody cocktails targeted at B-, T-, and Myeloid cell malignancies. For clinical laboratories, adopting the ClearLLab assays means reducing their number of Laboratory Developed Test (LDT) they need to develop and prepare, a technically demanding, time-consuming, and potentially error-prone process. ClearLLab reagents have been specifically designed for the fast and accurate identification of a number of haematolymphoid cell populations on the company’s FC500 flow cytometer.

*For Non-Hodgkin’s lymphoma only

Compliance with Clinical Guidelines

ClearLLab Reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia1. ClearLLab Reagents and ClearLLab LS are compatible with the World Health Organization (WHO) 2016-revised classification of myeloid neoplasms and acute leukemia2.

1 Davis BH, et al. 2006 Bethesda International Consensus Recommendations on the Immunophenotypic Analysis of Hematolymphoid Neoplasia by Flow Cytometry: Optimal Reagents and Reporting for the Flow Cytometric Diagnosis of Hematopoietic Neoplasia. Cytometry Part B (Clinical Cytometry 2007 72B: S5-S13

2 Vardiman JW, Arber DA, Brunning DR et al. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood 2009 114:937-951; doi: 10.1182/blood-2009-03-209262

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