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heartscare B-Ketone Test Strips (10pcs/Box) TD-4289

by Hearts Bio, Inc.

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 Number00850014861681 UDI-DI Date1 Oct 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  • Withdrawn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
heartscare B-Ketone Test Strips (10pcs/Box)
Generic Name
Ketone (acetoacetate) IVD, reagent
Model / Reference
TD-4289
Primary DI / UDI-DI
00850014861681
FDA Product Code
JIN
GMDN Term
Ketone (acetoacetate) IVD, reagent
Device Class
Class I
Regulation Number
862.1435
GUDID distribution status
In Commercial Distribution

Other devices from Hearts Bio, Inc.

See all devices from Hearts Bio, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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