FDA product code PMI: Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement
PMI is the FDA product code for fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement. It is a Class III device, reviewed by the Medical Genetics panel. Devices under PMI reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement |
| Device class | Class III |
| Review panel | MG — Medical Genetics |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PMI devices
openFDA lists no recalls for product code PMI.
Frequently asked questions
What is FDA product code PMI?
PMI is the FDA product code for fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement. It is a Class III device, reviewed by the Medical Genetics panel.
What device class is PMI?
Class III. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PMI
- Run a recall and safety report across every PMI manufacturer
- Watch product code PMI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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