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

GUDID 00859462006408

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, 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

• Primary Device ID: 00859462006408
• NIH Device Record Key: ee065a59-c87d-41d5-a94e-ced9bfdd52b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 23andMe, Inc. Personal Genome Service®(PGS)
• Version Model Number: YouDot
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859462006408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140044

FDA Product Code

• PKB: Autosomal Recessive Carrier Screening Gene Mutation Detection System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

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