Product code
QNB: Plasma processing system for converting alpha to pre-beta high-density lipoprotein
FDA product code · HDE · Gastroenterology/Urology
Key facts
| Product code | QNB |
|---|---|
| Device | Plasma processing system for converting alpha to pre-beta high-density lipoprotein |
| Device class | HDE |
| Review panel | Gastroenterology/Urology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database