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Hemosure F2-TC01

by Hemosure Inc.

Hemosure F2-TC01 is a device made by Hemosure Inc., listed in FDA GUDID since 30 Jun 2017 (UDI-DI 00857338006262), not in commercial distribution (GUDID) as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857338006262 UDI-DI Date30 Jun 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Hemosure
Generic name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
F2-TC01
Primary DI / UDI-DI
00857338006262
GMDN term
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
GUDID distribution status
Not in Commercial Distribution

Other devices from Hemosure Inc.

See all devices from Hemosure Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)