Device typeChronic lymphocytic leukaemia (CLL) 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 chronic lymphocytic leukaemia (CLL) based on changes at the gene or chromosomal level, which may involve genetic markers on chromosomes 11, 12, 13 and 17.
FDA categoryFluorescence in situ hybridization, chromosome 17p deletion (TP53)
Device ID00884999042780
Catalog number04N02-021
Single useYes
MRI safetyLabeling does not contain MRI Safety Information