FDA product code PRF: Docetaxel / Paclitaxel Assay
PRF is the FDA product code for docetaxel / paclitaxel assay. It is a Not classified device, reviewed by the Clinical Toxicology panel. Devices under PRF reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Measures levels of Docetaxel or Paclitaxel in the blood
Classification
| Field | Value |
|---|---|
| Device name | Docetaxel / Paclitaxel Assay |
| Device class | Not classified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PRF devices
openFDA lists no recalls for product code PRF.
Frequently asked questions
What is FDA product code PRF?
PRF is the FDA product code for docetaxel / paclitaxel assay. It is a Not classified device, reviewed by the Clinical Toxicology panel.
What device class is PRF?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PRF
- Run a recall and safety report across every PRF manufacturer
- Watch product code PRF 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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