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ProNephro AKI™ (NGAL) Calibrator Kit ST102UA

by Bioporto Diagnostics A/S 2 variants

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 Number05711435000163 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  • Withdrawn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) Calibrator Kit
Generic Name
Neutrophil gelatinase-associated lipocalin (NGAL) IVD, calibrator
Model / Ref / Catalog
ST102UA, 08787204190
Primary DI / UDI-DI
05711435000163
FDA Product Code
JIT
GMDN Term
Neutrophil gelatinase-associated lipocalin (NGAL) IVD, calibrator
Device Class
Class II
Regulation Number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

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

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