PJG

Cancer-Related Germline Gene Mutation Detection System

Product code: PJG
Device name: Cancer-Related Germline Gene Mutation Detection System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.

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

Official FDA classification page: PJG

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