FDA product code QVU: High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

QVU is the FDA product code for high throughput dna sequencing for hereditary cancer predisposition assessment test system.. It is a Class II device, regulated under 21 CFR 866.6095 and reviewed by the Pathology panel. Devices under QVU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QVU devices

openFDA lists no recalls for product code QVU.

Frequently asked questions

What is FDA product code QVU?

QVU is the FDA product code for high throughput dna sequencing for hereditary cancer predisposition assessment test system.. It is a Class II device, regulated under 21 CFR 866.6095 and reviewed by the Pathology panel.

What device class is QVU?

Class II, regulation 21 CFR 866.6095. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QVU
• Run a recall and safety report across every QVU manufacturer
• Watch product code QVU for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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