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Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA product code QDJ · 2 cleared devices

Class 2 Medical Genetics
Regulation
21 CFR 862.3364
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-08-17 – 2022-10-26

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.

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