FDA product code QNB: Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein
QNB is the FDA product code for plasma processing system for converting alpha to pre-beta high-density lipoprotein. It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under QNB reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
To reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia.
Classification
| Field | Value |
|---|---|
| Device name | Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for QNB devices
openFDA lists no recalls for product code QNB.
Frequently asked questions
What is FDA product code QNB?
QNB is the FDA product code for plasma processing system for converting alpha to pre-beta high-density lipoprotein. It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is QNB?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code QNB
- Run a recall and safety report across every QNB manufacturer
- Watch product code QNB 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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