QNC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Whole Exome Sequencing Constituent Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6000
- Medical specialty
- Medical Genetics
- 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.
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| Record | Firm | Date |
|---|---|---|
| Helix Laboratory Platform (DEN190035) | Helix Opco, LLC | 2020-12-23 |
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