QDJ

Direct-To-Consumer Access Pharmacogenetic Assessment System

Product code

QDJ

Device name

Direct-To-Consumer Access Pharmacogenetic Assessment System

Device class

Class 2

21 CFR

21 CFR 862.3364

Medical specialty

Medical Genetics

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.

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