510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PMIClass III

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

Unknown
FDA source (opens on fda.gov)

PMI is the FDA product code for Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement, a class III device type. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PMI
Device name
Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
FDA code 6
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PMI.