Device typePhiladelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mRNA expression of the Philadelphia chromosome, resulting from translocation t(9;22)(q34; q11) and rearrangement of the BCR and ABL genes, to diagnose, monitor or predict chronic myeloid leukaemia (CML) and/or a subset of acute lymphoblastic leukaemia (ALL) in a clinical specimen, using a nucleic acid technique (NAT).
FDA categoryBcr/Abl1 Monitoring Test
Device ID07332940007102
Catalog numberGXBCRABL-US-10
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information