FDA product code PSS: Minoxidil Sulfotransferase Or Isoenzymes Test System
PSS is the FDA product code for minoxidil sulfotransferase or isoenzymes test system. It is a Not classified device, reviewed by the Clinical Toxicology panel. Devices under PSS reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For measurement of Minoxidil sulfotransferase as an aid in assessing the likelihood that a patient will respond to minoxidil.
Classification
| Field | Value |
|---|---|
| Device name | Minoxidil Sulfotransferase Or Isoenzymes Test System |
| Device class | Not classified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PSS devices
openFDA lists no recalls for product code PSS.
Frequently asked questions
What is FDA product code PSS?
PSS is the FDA product code for minoxidil sulfotransferase or isoenzymes test system. It is a Not classified device, reviewed by the Clinical Toxicology panel.
What device class is PSS?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PSS
- Run a recall and safety report across every PSS manufacturer
- Watch product code PSS 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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