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CE Marked Diagnostic Assays (Not for sale in the US)
The IdentiClone™ IGH Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal immunoglobulin heavy chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ IGK Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal immunoglobulin kappa light chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ IGL Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal immunoglobulin lambda light chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ TCRB Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal T-cell receptor beta chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ TCRD Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal T-cell receptor delta chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ TCRG Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal T-cell receptor gamma chain gene rearrangements in patients with suspect lymphoproliferations.
The IdentiClone™ BCL1/JH Translocation Assay is an in vitro diagnostic product intended for PCR-based detection of BCL1/JH t(11;14)(q13;q32) gene translocations in patients with suspect lymphoproliferations.
The IdentiClone™ BCL2/JH Translocation Assay is an in vitro diagnostic product intended for PCR-based detection of BCL2/JH t(14;18) gene translocations in patients with suspect lymphoproliferations.
This LeukoStrat™ PCR assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and E836 mutations.