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

GUDID 00862150000060

Personal Genome Service (Genetic Reports)

23ANDME, INC.

Human genomic analysis interpretive software

• Primary Device ID: 00862150000060
• NIH Device Record Key: 643c23df-f654-42dc-aca6-3caf6a2a097a
• Commercial Distribution Discontinuation: 2018-07-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 23andMe, Inc. Personal Genome Service®(PGS)
• Version Model Number: YouDot
• Catalog Number: n/a
• Company DUNS: 780119710
• Company Name: 23ANDME, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com
• Phone: 1-800-239-5230
• Email: customercare@23andme.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859462006026 [Primary]
GS1	00862150000060 [Primary]

FDA Product Code

• PKB: Autosomal Recessive Carrier Screening Gene Mutation Detection System
• PTA: Genetic Variant Detection And Health Risk Assessment System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-11
• Device Publish Date: 2017-04-17

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

• 00862150000060: Personal Genome Service (Genetic Reports)
• 00859462006095: 23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Rep
• 00859462006118: 23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Rep
• 00859462006279: 23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Rep
• 00859462006262: 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
• 00859462006378: 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
• 00859462006385: 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
• 00859462006392: 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
• 00859462006408: 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re
• 00859462006415: 23andMe Personal Genome Service® (PGS) Includes: Carrier Status Reports, Genetic Health Risk Re