Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013145340

FEI Number

3013145340

Entity Name

TERRAGENE SA

City/State/Country

Alvear Santa Fe, AR

Establishment Address

Ruta Nacional No. 9, Km 280, Parque Industrial Micropi, Alvear Santa Fe 2130, AR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Terragene SA (Owner Number: 10056488)

Owner / Operator Contact Address

Ruta Nacional No 9 km 280, Parque Industrial Micropi, Alvear, AR-S 2130, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251122

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2023-05-03
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2023-05-03
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2020-07-09
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2019-09-18
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2019-09-18
QVB	Biological Sterilization Indicator With Indirect Growth Detection	General Hospital	Class 2	880.2806	2025-09-12
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2017-12-22
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-02-25
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-08-22

Official Correspondent

No official correspondent registered.

US Agent Details

Maximiliano Catalano Business: Terragene LLC Email: asuntos.regulatorios@terragene.com.ar Phone: (832) 9632416

Related Public Records

Same Entity

Terragene SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151482	Bcr Diagnostics, Inc.	BCR-30-min BI and RBIP-ST30 Readout Accessory	2016-02-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

Similar Registrations

Registration Number	Establishment Name	Location
3031841433	Solventum US LLC	San Antonio, TX, US
3031757047	Solventum US LLC	Brookings, SD, US
3042272797	SOLVENTUM US LLC	Eagan, MN, US
3016075971	Plasmapp Co., Ltd.	Asan-si Chungnam, KR
8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013145340. Last updated year: 2026. Please use registration number 3013145340 when referencing this establishment in official correspondence.