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Hemoccult 395065

by Beckman Coulter, Inc.

Hemoccult 395065 is a Class II device made by Beckman Coulter, Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 15099590221461), 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 Number15099590221461 UDI-DI Date23 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  • Withdrawn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
Hemoccult
Generic name
Faecal occult blood IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
395065
Primary DI / UDI-DI
15099590221461
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
In Commercial Distribution

Related devices

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

Similar devices

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

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)