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Giardia Stool Antigen Detection Assay GL2-96

by IVD Research, LLC.

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 Number00854624006074 UDI-DI Date13 Oct 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  • Withdrawn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
Giardia Stool Antigen Detection Assay
Generic Name
Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
Model / Reference
GL2-96
Primary DI / UDI-DI
00854624006074
FDA Product Code
MHI
GMDN Term
Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
866.3220
GUDID distribution status
In Commercial Distribution

Other devices from IVD Research, LLC.

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Properties

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No