Device typeAnaplastic lymphoma kinase (ALK) genetic mutation 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 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 categoryDna-probe kit, human chromosome, Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
Device ID00884999025721
Catalog number06N38-005
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information