PMI — Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement Class III
FDA product code PMI covers "Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PMI
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- MG
- Medical Specialty
- Unknown
- Implant
- No
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.