23andMe, Inc. Personal Genome Service®(PGS)

GUDID 00859462006279

23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Reports Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)) Pharmacogenetics Reports

23ANDME, INC.

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Primary Device ID00859462006279
NIH Device Record Keycca34b21-8a23-49b4-9909-edfd026a865f
Commercial Distribution StatusIn Commercial Distribution
Brand Name23andMe, Inc. Personal Genome Service®(PGS)
Version Model NumberYouDot
Company DUNS780119710
Company Name23ANDME, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com
Phone1-800-239-5230
Emailcustomercare@23andme.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859462006279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PTAGenetic Variant Detection And Health Risk Assessment System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-17
Device Publish Date2020-03-09

On-Brand Devices [23andMe, Inc. Personal Genome Service®(PGS)]

00862150000060Personal Genome Service (Genetic Reports)
0085946200609523andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Rep
0085946200611823andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Rep
0085946200627923andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Rep
0085946200626223andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
0085946200637823andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
0085946200638523andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
0085946200639223andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
0085946200640823andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
0085946200641523andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
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