Skip to content

EliA Stool Extraction Buffer plus 83-1187-01

by Phadia GmbH

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 Number07333066021829 UDI-DI Date25 Jun 2026ListedStatusListed 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  • Withdrawn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
EliA Stool Extraction Buffer plus
Generic Name
Calprotectin IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
83-1187-01
Primary DI / UDI-DI
07333066021829
FDA Product Code
KEM
GMDN Term
Calprotectin IVD, kit, enzyme immunoassay (EIA)
Device Class
Class I
Regulation Number
864.4010
GUDID distribution status
In Commercial Distribution

Other devices from Phadia GmbH

See all devices from Phadia GmbH →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Serial Number: No
  • Manufacturing Date: No