PMI

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

Product code

PMI

Device name

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

FDA classification definition

A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate.

Definition text from the FDA device classification database (U.S. federal government work, public domain).