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 Number: 3007699459
• FEI Number: 3007699459
• Name: 23ANDME, INC.
• Owner & Operator: 23andMe, Inc.
• Contact Address: 223 N. Mathilda Avenue ; Sunnyvale CA 94086 US
• Official Correspondent:
  • Lisa Charter
  • x-650-9339455-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 223 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	Device	Date
GUDID 00859462006415 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS)	2023-10-24
GUDID 00859462006408 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS)	2023-07-27
GUDID 00859462006392 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS)	2023-03-30
GUDID 00859462006385 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS)	2023-03-03
PMN K221885 23andMe, Inc.	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports	2022-10-26
GUDID 00859462006378 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS)	2022-06-01
PMN K211499 23andMe, Inc.	23andMe PGS Genetic Risk Report For Hereditary Prostate Cancer (HOXB13-Related)	2022-01-06
GUDID 00859462006262 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS)	2021-05-27
GUDID 00859462006279 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS)	2020-03-17
GUDID 00862150000060 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS) n/a	2019-09-11
GUDID 00859462006118 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS) n/a	2019-09-11
GUDID 00859462006095 23ANDME, INC.	23andMe, Inc. Personal Genome Service®(PGS) n/a	2019-09-11
PMN K182784 | QAZ 23ANDME, INC.	Cancer predisposition risk assessment system	2019-02-08
PMN K141410 | OYJ 23ANDME, INC.	DNA specimen collection, saliva	2019-02-08
PMN K182784 23andMe, Inc.	MUTYH-Associated Polyposis (MAP)	2019-01-18
PMN DEN180028 | QDJ 23ANDME, INC.	Direct-to-consumer access pharmacogenetic assessment system	2019-01-11
De Novo DEN180028 23andMe, Inc.	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports	2018-10-31
De Novo DEN170046 23andMe, Inc.	23andMe PGS Genetic Health Risk Report For BRCA1/BRCA2 (Selected Variants)	2018-03-06
PMN DEN170046 | QAZ 23ANDME, INC.	Cancer predisposition risk assessment system	2018-03-06
PMN DEN160026 | PTA 23ANDME, INC.	Genetic variant detection and health risk assessment system	2017-04-07
De Novo DEN160026 23andMe, Inc.	23andMe Personal Genome Service (PGS) Genetic Health Risk Test For Hereditary Thrombophilia	2017-04-06
PMN DEN140044 | PKB 23ANDME, INC.	Autosomal recessive carrier screening gene mutation detection system	2015-10-20

Related Finance Registrations

NCAGE Code	4TGW5	23ANDME, INC.
NCAGE Code	71ND8	23ANDME, INC.!DBA USE CAGE CODE 4TGW5 FOR!CATALOGING
CAGE Code	4TGW5	23ANDME, INC.
CAGE Code	71ND8	23ANDME, INC. USE CAGE CODE 4TGW5 FOR CATALOGING
S.A.M. Registration	4TGW5 [780119710]	23ANDME, INC.
SEC	0001414053	23andMe, Inc. of DELAWARE