Product code QNC

Device name

Whole Exome Sequencing Constituent Device

Medical specialty

Medical Genetics

Device class

2

Regulation number

866.6000

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset