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QNC — Whole Exome Sequencing Constituent Device Class II

FDA Device Classification

Classification Details

Product Code
QNC
Device Class
Class II
Regulation Number
866.6000
Submission Type
Review Panel
PA
Medical Specialty
Medical Genetics
Implant
No

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.