Device typeAcute myeloid leukaemia (AML) genetic mutation IVD, probe: A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict acute myeloid leukaemia (AML) based on changes at the gene or chromosomal level which may include FLT3 gene mutations, NPM1 gene mutations, t(8;21), inv(16) and/or t(15;17).
FDA categoryRevumenib Eligibility Detection System
Device ID05055844934894
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information