Device typePhiladelphia chromosome/BCR-ABL transcript IVD, control: A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict chronic myeloid leukaemia (CML) or a subset of acute lymphoblastic leukaemia (ALL) associated with the Philadelphia chromosome, resulting from translocation t(9;22)(q34;q11) and rearrangement of the BCR and ABL genes.
FDA categoryQuality Control Material, Genetics, Rna
Device ID00852720008336
Catalog numberC230
Single useYes
MRI safetyLabeling does not contain MRI Safety Information