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Direct-To-Consumer Access Pharmacogenetic Assessment System

Direct-To-Consumer Access Pharmacogenetic Assessment System is a medical device type in the Medical Genetics specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

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Direct-To-Consumer Access Pharmacogenetic Assessment System
Medical Genetics Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QDJ

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Class 2

21 CFR 862.3364

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Medical Genetics

Device Characteristics

No

No

No

Not Eligible

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.