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Gastrocult 66040

by Beckman Coulter, 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 Number15099590229597 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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
Gastrocult
Generic Name
Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog
66040
Primary DI / UDI-DI
15099590229597
FDA Product Code
KHE
GMDN Term
Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
Device Class
Class II
Regulation Number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical

Other devices from Beckman Coulter, Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No