BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    careGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit

    Reg #: 3013346273 · FEI: 3013346273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WELLS BIO, INC.
    Registration Number
    3013346273
    FEI Number
    3013346273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    16, Magokjungang 8-ro 1-gil, Gangseo-gu,
    City
    Seoul
    Country
    KR

    Owner / Operator

    Firm Name
    WELLS BIO, INC.
    Operator Number
    10055534
    Address
    16, Magokjungang 8-ro 1-gil, Gangseo-gu,
    City
    Seoul
    State
    KR-11
    Postal Code
    07795
    Country
    KR
    Correspondent
    Hyunkyung Bae

    US Agent

    Business Name
    Access Bio, Inc.
    Contact Name
    Sung Jang
    Address
    65 Clyde Road, Suite A
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    732 8734040

    Products

    Device Name Product Code
    Clinical Sample Concentrator JJH

    Proprietary Names

    careGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit careGENE™ HiFi Nucleic Acid Isolation kit for P1 system careGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit-N careSTART™ P1 System

    Establishment Types

    Manufacture Medical Device