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    FDA Registration Active 🇦🇷 Argentina

    Terragene Bionova® IC10/20FR Reader Incubator

    Reg #: 3013145340 · FEI: 3013145340 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    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
    K163646

    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

    Proprietary Names

    Terragene Bionova® IC10/20FR Reader Incubator Terragene Bionova® SCBI (BT220, BT222) 73105 BIOTRACE™ Auto Read 60 Steam Biological Indicator 73135 BIOTRACE™ Auto Read 60 Steam BI Process Challenge Device Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2)

    Establishment Types

    Manufacture Medical Device