Device |
whole exome sequencing constituent device |
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. |
Product Code | QNC |
Regulation Number |
866.6000
|
Device Class |
2
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