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23andMe Genomics LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
3007699459300769945923andMe Genomics LLC1N2026-01-012555 Park Blvd Palo Alto CA US 94306

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
0085946200602623andMe, Inc. Personal Genome Service®(PGS) - Personal Genome Service (Genetic Reports)1-800-239-5230customercare@23andme.com
0085946200627923andMe, Inc. Personal Genome Service®(PGS) - 23andMe Personal Genome Service® (PGS)Includes :Carrier Status ReportGenetic Health Risk ReportsCancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP))Pharmacogenetics Reports1-800-239-5230customercare@23andme.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1037471585063331K22359723andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)QAZ2023-08-31
1037471519313895K22188523andMe Personal Genome Service (PGS) Pharmacogenetic ReportsQDJ2022-10-26
1037471941693268K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)QAZ2022-01-06
1037471845351041K19349223andMe Personal Genome Service (PGS) Pharmacogenetic ReportsQDJ2020-08-17
1037471535398254K182784MUTYH-Associated Polyposis (MAP)QAZ2019-01-18
1037471759691221K141410ORAGENE DX OGD-500.001OYJ2015-02-19
1037471146132112DEN18002823andMe Personal Genome Service (PGS) Pharmacogenetic ReportsQDJ2018-10-31
1037472003144766DEN17004623andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)QAZ2018-03-06
1037471870874898DEN16002623andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary ThrombophiliaPTA2017-04-06
1037471562804970DEN14004423ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)PKB2015-02-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QAZ42023-08-31
QDJ32022-10-26
PTA12017-04-06
OYJ12015-02-19
PKB12015-02-19

GUDID#

23andMe, Inc. Personal Genome Service®(PGS) - 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, CYP2C19 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight, BRCA1/BRCA2 (Selected Variants) report update

23ANDME GENOMICS LLC

2023-10-16

23andMe, Inc. Personal Genome Service®(PGS) - 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Reports, Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)), Pharmacogenetics, SLCO1B1 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight

23ANDME GENOMICS LLC

2023-07-19