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Biomeme GoDx App for US 2.3.5

by Biomeme, Inc.

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 Number00810096640130 UDI-DIDate2 Dec 2022ListedStatusListed 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  • Withdrawn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
Biomeme GoDx App for US
Generic Name
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Reference
2.3.5
Primary DI / UDI-DI
00810096640130
FDA Product Code
QJR
GMDN Term
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
N
GUDID distribution status
Not in Commercial Distribution

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No