QDJClass II
Direct-to-consumer Access Pharmacogenetic Assessment System
Medical Genetics · 21 CFR 862.3364
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.
MDR events1All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances3All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
3 clearances for this product code