1 device · 1 company · 2017
Product code PTA: Genetic Variant Detection And Health Risk Assessment System
1 device under product code PTA, 2017, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Genetic Variant Detection And Health Risk Assessment System. 21 CFR 866.5950, Class II. 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 persons overall risk of developing a disease. MAUDE held 7 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| 23andMe Personal Genome ServiceDEN160026 · De Novo | 23andMe, Inc. | Immunology | database entry |
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