Whole Exome Sequencing Constituent Device
QNC is the FDA product code for Whole Exome Sequencing Constituent Device, a class II device type, regulated under 21 CFR 866.6000. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QNC
- Device name
- Whole Exome Sequencing Constituent Device
- FDA 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.
- Regulation
- 21 CFR 866.6000
- Device class
- Class II
- Review panel
- Medical Genetics
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QNC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2020 | 1 |
Applicants with the most clearances
Product code QNC| Applicant | Clearances |
|---|---|
| Helix Opco, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QNC.
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