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Henry Schein 1127141

by Henry Schein, Inc.

Henry Schein 1127141 is a Class II device made by Henry Schein, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040002599), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00304040002599 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: 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  • Withdrawn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
Henry Schein
Generic name
Faecal occult blood IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog
1127141
Primary DI / UDI-DI
00304040002599
FDA product code
KHE
GMDN term
Faecal occult blood IVD, kit, rapid colorimetric, clinical
Device class
Class II
Regulation number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal occult blood IVD, kit, rapid colorimetric, clinical

Similar devices

Other devices filed under FDA product code KHE (REAGENT, OCCULT BLOOD).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

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