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23andMe, Inc. Personal Genome Service® YouDot (Carrier)

by 23andMe Genomics LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862150000060 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
23andMe, Inc. Personal Genome Service®
Generic Name
Human genomic analysis interpretive software
Model / Reference
YouDot (Carrier)
Primary DI / UDI-DI
00862150000060
FDA Product Code
PKB
GMDN Term
Human genomic analysis interpretive software
Device Class
Class II
Regulation Number
866.5940
GUDID distribution status
Not in Commercial Distribution

Other devices from 23andMe Genomics LLC

Properties

  • Single Use
  • Over-the-Counter

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No