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

PMI · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: PMI
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: MG
Medical specialty: Unknown
Submission type: 6
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown