Product code
NQC: Test, breath analysis, volatile organic compounds
FDA product code · HDE · Clinical Chemistry
Key facts
| Product code | NQC |
|---|---|
| Device | Test, breath analysis, volatile organic compounds |
| Device class | HDE |
| Review panel | Clinical Chemistry |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None 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