Product code PQP

Device name

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

Medical specialty

Unknown

Device class

3

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset