QNC

Whole Exome Sequencing Constituent Device

Product code

QNC

Device name

Whole Exome Sequencing Constituent Device

Device class

Class 2

21 CFR

21 CFR 866.6000

Medical specialty

Medical Genetics

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).