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GeroaDX 1

by Geroa Diagnostics Sociedad Limitada.

Listed FDA GUDID listing, no authorization on record

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08437029987012 UDI-DI Date10 Dec 2025ListedStatusListed GUDID: 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  • Withdrawn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
GeroaDX
Generic Name
Lactoferrin IVD, kit, enzyme immunoassay (EIA)
Model / Reference
1
Primary DI / UDI-DI
08437029987012
FDA Product Code
DEG
GMDN Term
Lactoferrin IVD, kit, enzyme immunoassay (EIA)
Device Class
Class I
Regulation Number
866.5570
GUDID distribution status
In Commercial Distribution

Properties

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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