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

by 23andMe Genomics LLC 4 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00859462006279 UDI-DI Date9 Mar 2020ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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®(PGS)
Generic Name
Human genomic analysis interpretive software
Model / Reference
YouDot
Primary DI / UDI-DI
00859462006279
510(k) Number
De Novo Number
FDA Product Code
PTA, PKB, QAZ, QDJ
GMDN Term
Human genomic analysis interpretive software
Device Class
Class II
Regulation Number
866.5950, 866.5940, 866.6090, 862.3364
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