Device typeNucleic acid hybridization detection IVD, reagent: A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].
FDA categoryFluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
Device ID00884999038189
Catalog number08N16-001
Single useYes
MRI safetyLabeling does not contain MRI Safety Information