Device typeAnaplastic lymphoma kinase (ALK) 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 genetic mutations of the anaplastic lymphoma kinase (ALK) gene, also known as ALK gene. The changes detected at the gene or chromosome level may include ALK gene rearrangement, or NPM-ALK or EML4-ALK fusion genes formed by translocation.
FDA categoryFluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
Device ID00884999042773
Catalog number06N38-053
Single useYes
MRI safetyLabeling does not contain MRI Safety Information