Whole Exome Sequencing Constituent Device

QNC · Class II — Moderate Risk (510(k) clearance required) · Medical Genetics · 21 CFR 866.6000

Classification

FDA Product Code: QNC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6000
Review panel: PA
Medical specialty: Medical Genetics
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown