PQP

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Product code: PQP
Device name: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.

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

Official FDA classification page: PQP

Classification and pathway per current FDA publications. Data from openFDA (CC0).