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ProNephro AKI™ (NGAL) Control Kit ST103UA

by Bioporto Diagnostics A/S

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05711435000170 UDI-DIDate28 Aug 2025ListedStatusListed 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  • Withdrawn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
ProNephro AKI™ (NGAL) Control Kit
Generic Name
Neutrophil gelatinase-associated lipocalin (NGAL) IVD, control
Model / Ref / Catalog
ST103UA, 08787212190
Primary DI / UDI-DI
05711435000170
FDA Product Code
JJX
GMDN Term
Neutrophil gelatinase-associated lipocalin (NGAL) IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neutrophil gelatinase-associated lipocalin (NGAL) IVD, control

Other devices from Bioporto Diagnostics A/S

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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