23andme Inc

FDA Filings

This page includes the latest FDA filings for 23andme Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3007699459
FEI Number3007699459
Name23ANDME, INC.
Owner & Operator23andMe, Inc.
Contact Address223 N. Mathilda Avenue
Sunnyvale CA 94086 US
Official Correspondent
  • Lisa Charter
  • x-650-9339455-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address223 N Mathilda Ave
Sunnyvale, CA 94086 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
23andMe, Inc.
23andMe PGS Genetic Risk Report For Hereditary Prostate Cancer (HOXB13-Related)2022-01-06
23ANDME, INC.
23andMe, Inc. Personal Genome Service®(PGS) 2021-05-27
23ANDME, INC.
23andMe, Inc. Personal Genome Service®(PGS) 2020-03-17
23ANDME, INC.
23andMe, Inc. Personal Genome Service®(PGS) n/a2019-09-11
23ANDME, INC.
23andMe, Inc. Personal Genome Service®(PGS) n/a2019-09-11
23ANDME, INC.
23andMe, Inc. Personal Genome Service®(PGS) n/a2019-09-11
23ANDME, INC.
Cancer predisposition risk assessment system2019-02-08
23ANDME, INC.
DNA specimen collection, saliva2019-02-08
23andMe, Inc.
MUTYH-Associated Polyposis (MAP)2019-01-18
23ANDME, INC.
Direct-to-consumer access pharmacogenetic assessment system2019-01-11
23andMe, Inc.
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports2018-10-31
23andMe, Inc.
23andMe PGS Genetic Health Risk Report For BRCA1/BRCA2 (Selected Variants)2018-03-06
23ANDME, INC.
Cancer predisposition risk assessment system2018-03-06
23ANDME, INC.
Genetic variant detection and health risk assessment system2017-04-07
23andMe, Inc.
23andMe Personal Genome Service (PGS) Genetic Health Risk Test For Hereditary Thrombophilia2017-04-06
23ANDME, INC.
Autosomal recessive carrier screening gene mutation detection system2015-10-20

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