Product code QVU

Device name

High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

Medical specialty

Pathology

Device class

2

Regulation number

866.6095

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only.

Source

FDA openFDA device classification dataset