Device typeNucleic acid hybridization detection IVD, probe: A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].
FDA categoryChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Device ID07613336158432
Catalog number08314365001
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information