BEUDAMED
    FDA Registration Active 🇦🇷 Argentina

    Terragene Chemdye® (CD16, CD29)

    Reg #: 3013145340 · FEI: 3013145340 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TERRAGENE SA
    Registration Number
    3013145340
    FEI Number
    3013145340
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ruta Nacional No. 9, Km 280, Parque Industrial Micropi
    City
    Alvear Santa Fe
    Country
    AR

    Regulatory Submissions

    510(k) Number
    K191021

    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 D800
    City
    Spring
    State
    TX
    ZIP
    77386
    Country
    US
    Email
    [email protected]
    Phone
    844 8377243

    Products

    Device Name Product Code
    Indicator, Biological Sterilization Process FRC
    Indicator, Physical/Chemical Sterilization Process JOJ

    Proprietary Names

    Terragene Chemdye® (CD16, CD29) Terragene Cintape® (CT22) Terragene Bionova® SCBI (BT96, BT110, BT224) Terragene Bionova® Reader Incubators (IC10/20FRLCD, MiniBio) Terragene Bionova® PCD (PCD224-C, PCD224-2) Terragene Integron® (IT12, IT26-1YS, IT26-C, IT26-C with extender, PCD26-C) 73350 VERISURE™ EO Type 4 Multi-Variable Chemical Indicator Strip 73155 VERISURE™ Steam Type 5 Migrating Integrator w/ Extender 73400 BIOTRACE™ Auto Read Pro Biological Indicator Reader 73300 BIOTRACE™ Auto Read 4H EO Biological Indicator 73170 SEALSURE™ Steam Indicator Tape 18mm 73210 BIOTRACE™ Auto Read 30 VH2O2 Biological Indicator 73156 VERISURE™ Steam Type 5 Ink Integrator 73260 VERISURE™ VH2O2 Type 1 Chemical Indicator Strip 73100 BIOTRACE™ Auto Read 20 Steam Biological Indicator 73270 SEALSURE™ VH2O2 Indicator Tape 20mm 73130 BIOTRACE™ Auto Read 20 Steam BI Process Challenge Device 73165 VERISURE™ Steam Type 4 Multi-Variable Chemical Indicator 73410 BIOTRACE™ Auto Read Mini Biological Indicator Reader 73250 VERISURE™ VH2O2 Type 4 Multi-Variable Chemical Indicator Strip 73160 VERISURE™ Steam Type 5 Migrating Integrator Process Challenge Device 73150 VERISURE™ Steam Type 5 Migrating Integrator

    Establishment Types

    Manufacture Medical Device