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Cryptosporidium Stool Antigen Detection Assay CP2-96

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 Number00854624006036 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  • Withdrawn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
Cryptosporidium Stool Antigen Detection Assay
Generic Name
Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)
Model / Reference
CP2-96
Primary DI / UDI-DI
00854624006036
FDA Product Code
MHJ
GMDN Term
Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
866.3220
GUDID distribution status
In Commercial Distribution

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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