FDA product code QNC: Whole Exome Sequencing Constituent Device
QNC is the FDA product code for whole exome sequencing constituent device. It is a Class II device, regulated under 21 CFR 866.6000 and reviewed by the Pathology panel. Devices under QNC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.
Classification
| Field | Value |
|---|---|
| Device name | Whole Exome Sequencing Constituent Device |
| Device class | Class II |
| Regulation | 21 CFR 866.6000 |
| Review panel | PA — Pathology |
| Medical specialty | Medical Genetics |
| Premarket route | 510(k) |
Recalls for QNC devices
openFDA lists no recalls for product code QNC.
Frequently asked questions
What is FDA product code QNC?
QNC is the FDA product code for whole exome sequencing constituent device. It is a Class II device, regulated under 21 CFR 866.6000 and reviewed by the Pathology panel.
What device class is QNC?
Class II, regulation 21 CFR 866.6000. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QNC
- Run a recall and safety report across every QNC manufacturer
- Watch product code QNC 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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