AccessGUDID - DEVICE: 23andMe, Inc. Personal Genome Service®(PGS) (00859462006415)

GUDID

Device Identifier (DI) Information

Brand Name: 23andMe, Inc. Personal Genome Service®(PGS)
Version or Model: YouDot
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 23ANDME, INC.

Primary DI Number: 00859462006415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 780119710 *Terms of Use

Device Description: 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, CYP2C19 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, BRCA1/BRCA2 (Selected Variants) report update

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61777	Human genomic analysis interpretive software	An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile. This software is not an IVD device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKB	Autosomal Recessive Carrier Screening Gene Mutation Detection System
QDJ	Direct-To-Consumer Access Pharmacogenetic Assessment System
QAZ	Cancer Predisposition Risk Assessment System
PTA	Genetic Variant Detection And Health Risk Assessment System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN140044	000
DEN160026	000
DEN170046	000
DEN180028	000
K182784	000
K193492	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b11e21e-300b-4070-bcf6-674696a8e73d
Public Version Date: October 24, 2023
Public Version Number: 1
DI Record Publish Date: October 16, 2023