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

GUDID 00862150000060

Personal Genome Service (Genetic Reports)

23ANDME, INC.

Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software Human genomic analysis interpretive software
Primary Device ID00862150000060
NIH Device Record Key643c23df-f654-42dc-aca6-3caf6a2a097a
Commercial Distribution Discontinuation2018-07-17
Commercial Distribution StatusNot in Commercial Distribution
Brand Name23andMe, Inc. Personal Genome Service®(PGS)
Version Model NumberYouDot
Catalog Numbern/a
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
Phone1-800-239-5230
Emailcustomercare@23andme.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859462006026 [Primary]
GS100862150000060 [Primary]

FDA Product Code

PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System
PTAGenetic Variant Detection And Health Risk Assessment System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-11
Device Publish Date2017-04-17

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.