Home › Device types › PIG
Acute Kidney Injury Test System
FDA product code PIG · Class 2 · Clinical Chemistry
10
Registered devices
1
Adverse events
1
Recalls
5
510(k) clearances
Devices with this code
VIDAS® NEPHROCHECK® — BIOMERIEUX SANEPHROCHECK Liquid Control Kit — BIOMERIEUX SAProNephro AKI™ (NGAL) Calibrator Kit — Bioporto Diagnostics A/SASTUTE140 Meter Kit — BIOMERIEUX SANEPHROCHECK Test Kit — BIOMERIEUX SAProNephro AKI™ (NGAL) Reagent Kit — Bioporto Diagnostics A/SProNephro AKI™ (NGAL) Control Kit — Bioporto Diagnostics A/SASTUTE140 Electronic Quality Control (EQC) Device — BIOMERIEUX SAProNephro AKI™ (NGAL) Reagent Kit — Bioporto Diagnostics A/SNEPHROCHECK Calibration Verification (Cal Vers) Kit — BIOMERIEUX SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | Bioporto Diagnostics A/S | The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappr |
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