Dynex Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2345-2025Class IIDynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/conJuly 16, 2025
Z-1222-2022Class IIDYNEX Agility, Agility Analyzer, Model No. 67000July 5, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K212769DYNEX SmartPLEX MMRV IgG Assay KitSeptember 29, 2023