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Genetic Variant Detection And Health Risk Assessment System

FDA product code PTA · 4 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5950
Review panel
IM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-08-13 – 2025-01-07

A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the person’s overall risk of developing a disease.

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