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Hemosure T1-CK30

by Hemosure Inc.

Hemosure T1-CK30 is a Class II device made by Hemosure Inc., listed in FDA GUDID since 9 May 2016 (UDI-DI 00857338006019), 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 Number00857338006019 UDI-DI Date9 May 2016ListedStatusListed 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  • Withdrawn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
Faecal occult blood IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
T1-CK30
Primary DI / UDI-DI
00857338006019
FDA product code
KHE
GMDN term
Faecal occult blood IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
864.6550
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code KHE (Reagent, Occult Blood).

Other devices from Hemosure Inc.

See all devices from Hemosure Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)