QVU

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

Product code

QVU

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.6095

Medical specialty

Pathology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification 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.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-29.