FDA.reportPublic FDA data

De Novo DEN170046

Device
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Contact
lisa charter
De Novo number
DEN170046
Product code
QAZ
Regulation
866.6090
Classification name
cancer predisposition risk assessment system
Decision
granted (DENG)
Decision date
2018-03-06
Date received
2017-09-05
Classification advisory
Molecular Genetics
Review advisory
Pathology
Type
Direct

Current FDA Classification#

Product code
QAZ
Device name
Cancer Predisposition Risk Assessment System
Medical specialty
Medical Genetics
Device class
2
Regulation
866.6090
Implant
N
Life sustain/support
N