Data / Medical devices / Argentina / Terragene SA
Terragene SA: FDA-registered device maker in Alvear Santa Fe, Argentina, 8 510(k) clearances
Terragene SA is registered with the FDA (registration 3013145340) in Alvear Santa Fe, Argentina. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 4, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013145340
- Address
- Ruta Nacional No. 9, Km 280 Parque Industrial Micropi, Alvear Santa Fe, Argentina, 2130
- Owner or operator
- Terragene SA (10056488)
- Roles
- Manufacturer
- First device listed
- December 22, 2017
- Registered through
- 2026
- Brand names listed
- 73100 BIOTRACE Auto Read 20 Steam Biological Indicator, 73105 BIOTRACE Auto Read 60 Steam Biological Indicator, 73110 BIOTRACE Instant Read Steam Biological Indicator;, 73120 BIOTRACE 24h Steam Biological Indicator, 73130 BIOTRACE Auto Read 20 Steam BI Process Challenge Device, 73135 BIOTRACE Auto Read 60 Steam BI Process Challenge Device, 73140 BIOTRACE Instant Read Steam BI Process Challenge Device, 73150 VERISURE Steam Type 5 Migrating Integrator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | 2 | Manufacturer | accessdata.fda.gov |
| Biological Sterilization Indicator With Indirect Growth Detection | QVB | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 4, 2025 | K251122 | Terragene® Bionova® BT20 Biological Indicator | FRC | Substantially Equivalent | Terragene | accessdata.fda.gov |
| December 12, 2024 | 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) | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| July 12, 2024 | DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | QVB | Unknown | Terragene S.A. | accessdata.fda.gov |
| April 5, 2024 | K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | QKM | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| February 28, 2023 | K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| June 30, 2020 | K200272 | Terragene Chemdye | JOJ | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| September 13, 2019 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| November 2, 2017 | 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 | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 15, 2025 | 96176 | Class II | Ongoing | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. | accessdata.fda.gov |
| December 7, 2023 | 93625 | Class II | Ongoing | 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) | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Biological Sterilization Process
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of A Chemical Vapor Sterilization Multivariable Chemical Indicator
Updated August 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.