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

• 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