Bioporto Diagnostics A/S

FDA Regulatory Profile

Bioporto Diagnostics A/S appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2937-2026, Class II) was initiated on May 18, 2026.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2937-2026Class IIProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.May 18, 2026