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heartscare Total Cholesterol Test Strip (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 Number00850014861834 UDI-DI Date17 Apr 2026ListedStatusListed 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  • Withdrawn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 Total Cholesterol Test Strip (10pcs/box)
Generic Name
Total cholesterol lipid IVD, reagent
Model / Reference
TD-4289
Primary DI / UDI-DI
00850014861834
FDA Product Code
CHH
GMDN Term
Total cholesterol lipid IVD, reagent
Device Class
Class I
Regulation Number
862.1175
GUDID distribution status
In Commercial Distribution

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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