# Terragene S.A.

- Location (FDA's records): Alvear, AR
- FDA decisions: 9 (2017–2025): 8 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Terragene S.A. (8); Terragene (1)
- Product codes: FRC (6), JOJ (1), QVB (1), QKM (1)
- 510(k) review time since 2016: median 149 days, against 105 for FDA's reviews in the same codes and years (0 of 7 faster)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 9 (2 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Propper Manufacturing Co., Inc.: 2 (https://510kreport.com/company/propper-manufacturing)
- True Indicating, LLC: 2 (https://510kreport.com/company/true-indicating)
- Plasmapp Co,., Ltd.: 1 (https://510kreport.com/company/plasmapp)
- Shenzhen Safesecure Medical Infection Control Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-safesecure-medical-infection-control-tech)
- Steritec Products, Inc.: 1 (https://510kreport.com/company/steritec-products)

## Its most-cited devices
- K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye (2019), cited by 6
- DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) (2024), cited by 2
- 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 (2017), cited by 1

## Recent decisions
- K251122: Terragene® Bionova® BT20 Biological Indicator (Aug 4, 2025)
- K242453: Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) (Dec 12, 2024)
- 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) (Sep 18, 2024)
- DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) (Jul 12, 2024)
- K232103: Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (Apr 5, 2024)
- K221641: Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) (Feb 28, 2023)
- K200272: Terragene Chemdye (Jun 30, 2020)
- K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye (Sep 13, 2019)

Source page: https://510kreport.com/company/terragene