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TERRAGENE S.A.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
9
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1248-2025Class IIASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.January 15, 2025
Z-0836-2024Class IITerragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical IntegrDecember 7, 2023
Z-0837-2024Class IITerragene Bionova PCD (PCD222-C)December 7, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K251122Terragene® Bionova® BT20 Biological IndicatorAugust 4, 2025
K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);TerragenDecember 12, 2024
K231383Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained BSeptember 18, 2024
DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader IncubatoJuly 12, 2024
K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process InApril 5, 2024
K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader IncubatFebruary 28, 2023
K200272Terragene ChemdyeJune 30, 2020
K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeSeptember 13, 2019
K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-November 2, 2017