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ProNephro AKI™ (NGAL) Calibrator Kit ST102UA

by Bioporto Diagnostics A/S 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number05711435000255 UDI-DIDate2 Aug 2024ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2937-2026 FDA Class II initiated 18 May 2026

    The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.

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  • Withdrawn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 / Reference
ST102UA
Primary DI / UDI-DI
05711435000255
510(k) Number
FDA Product Code
PIG
GMDN Term
Neutrophil gelatinase-associated lipocalin (NGAL) IVD, calibrator
Device Class
Class II
Regulation Number
862.1220
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K232761)

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