FDA Registration
Active
🇦🇷 Argentina
TERRAGENE SA
Reg #: 3013145340
·
FEI: 3013145340
·
Expires 2026
Products
4
Proprietary Names
48
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- TERRAGENE SA
- Registration Number
- 3013145340
- FEI Number
- 3013145340
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ruta Nacional No. 9, Km 280, Parque Industrial Micropi
- City
- Alvear Santa Fe
- Country
- AR
Regulatory Submissions
- 510(k) Number
- K221641
Owner / Operator
- Firm Name
- Terragene SA
- Operator Number
- 10056488
- Address
- Ruta Nacional No 9 km 280, Parque Industrial Micropi
- City
- Alvear
- State
- Santa Fe
- Postal Code
- 2130
- Country
- AR
US Agent
- Business Name
- Terragene LLC
- Contact Name
- Maximiliano Catalano
- Address
- 25003 Pitkin Rd Ste G400
- City
- Spring
- State
- TX
- ZIP
- 77386
- Country
- US
- [email protected]
- Phone
- 832 9632416
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2023-05-03 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2023-05-03 |
| Biological Sterilization Indicator With Indirect Growth Detection | QVB | Class 2 | General Hospital | No | 2025-09-12 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2024-06-19 |
Proprietary Names
Terragene® Bionova® Hyper Auto-reader Incubator (BHY)
Terragene® Bionova® Hyper Biological Indicator (BT98)
73200 BIOTRACE Rapid Read 5 VH2O2 Biological Indicator
73420 BIOTRACE Rapid Read 5 VH2O2 Biological Indicator Reader
Terragene Chemdye® BD8948X/1 Bowie-Dick Test Card
Terragene Chemdye® BD125X/1 Bowie-Dick Test Pack
73191 VERISURE Bowie-Dick Test Card
73180 VERISURE Bowie-Dick Test Pack
73190 VERISURE Bowie-Dick Test Card Kit
Terragene Cintape® (CT22)
Terragene Bionova® Reader Incubators (IC10/20FRLCD, MiniBio)
Terragene Bionova® SCBI (BT96, BT110, BT224)
Terragene Integron® (IT12, IT26-1YS, IT26-C, IT26-C with extender, PCD26-C)
Terragene Bionova® PCD (PCD224-C, PCD224-2)
73270 SEALSURE VH2O2 Indicator Tape 20mm
73260 VERISURE VH2O2 Type 1 Chemical Indicator Strip
73350 VERISURE EO Type 4 Multi-Variable Chemical Indicator Strip
73100 BIOTRACE Auto Read 20 Steam Biological Indicator
73300 BIOTRACE Auto Read 4H EO Biological Indicator
73150 VERISURE Steam Type 5 Migrating Integrator
73155 VERISURE Steam Type 5 Migrating Integrator w/ Extender
73165 VERISURE Steam Type 4 Multi-Variable Chemical Indicator
73130 BIOTRACE Auto Read 20 Steam BI Process Challenge Device
73170 SEALSURE Steam Indicator Tape 18mm
73410 BIOTRACE Auto Read Mini Biological Indicator Reader
73160 VERISURE Steam Type 5 Migrating Integrator Process Challenge Device
73250 VERISURE VH2O2 Type 4 Multi-Variable Chemical Indicator Strip
73400 BIOTRACE Auto Read Pro Biological Indicator Reader
73156 VERISURE Steam Type 5 Ink Integrator
73210 BIOTRACE Auto Read 30 VH2O2 Biological Indicator
Terragene Chemdye® (CD16, CD29)
Terragene® Bionova® Photon Biological Indicator (BT225)
Terragene® Bionova® Photon Auto-Reader Incubator (BPH)
73430 BIOTRACE Instant Read Steam Biological Indicator Reader
73110 BIOTRACE Instant Read Steam Biological Indicator;
Terragene Bionova® SCBI (BT220, BT222)
Terragene Bionova® IC10/20FR Reader Incubator
73135 BIOTRACE Auto Read 60 Steam BI Process Challenge Device
Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2)
73105 BIOTRACE Auto Read 60 Steam Biological Indicator
Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2)
73140 BIOTRACE Instant Read Steam BI Process Challenge Device
Terragene® Bionova® BT20 Biological Indicator
73120 BIOTRACE 24h Steam Biological Indicator
Terragene® Chemdye® Chemical Process Indicator (CD42)
Terragene® Chemdye® Multivariable Chemical Indicator (CD40)
Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Establishment Types
Manufacture Medical Device