QDJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Direct-To-Consumer Access Pharmacogenetic Assessment System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3364
- Medical specialty
- Medical Genetics
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (K221885) | 23AndMe, Inc. | 2022-10-26 | + Add |
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (K193492) | 23AndMe, Inc. | 2020-08-17 | + Add |
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (DEN180028) | 23AndMe, Inc. | 2018-10-31 |
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Every clearance here is in the API, with alerts when new ones post.