Terragene S.A.
Terragene S.A. holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2024, with 3 FDA device recalls on record.
Top product codes for Terragene S.A.
FDA recalls by Terragene S.A.
- Z-1248-2025 — ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Z-0837-2024 — Terragene Bionova PCD (PCD222-C)
- Z-0836-2024 — Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Terragene S.A.
- K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) +1 more
- K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
- K200272 — Terragene Chemdye
- K191021 — Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
- K163646 — Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator
Data sourced from openFDA. This site is unofficial and independent of the FDA.