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Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit C/G-DFA

by IVD Research, LLC.

Listed FDA GUDID listing, not in commercial distribution

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 Number00854624006005 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit
Generic Name
Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
C/G-DFA
Primary DI / UDI-DI
00854624006005
GMDN Term
Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)

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Properties

  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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