FDA product code NQC: Test, Breath Analysis, Volatile Organic Compounds
NQC is the FDA product code for test, breath analysis, volatile organic compounds. It is a HDE device, reviewed by the Clinical Chemistry panel. Devices under NQC reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients
Classification
| Field | Value |
|---|---|
| Device name | Test, Breath Analysis, Volatile Organic Compounds |
| Device class | HDE |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for NQC devices
openFDA lists no recalls for product code NQC.
Frequently asked questions
What is FDA product code NQC?
NQC is the FDA product code for test, breath analysis, volatile organic compounds. It is a HDE device, reviewed by the Clinical Chemistry panel.
What device class is NQC?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code NQC
- Run a recall and safety report across every NQC manufacturer
- Watch product code NQC 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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