BEUDAMED
    FDA Registration Active 🇨🇳 China

    Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus

    Reg #: 3016733849 · FEI: 3016733849 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.
    Registration Number
    3016733849
    FEI Number
    3016733849
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.888, Zhujiang Road, Juegang Street, Rudong County, Life and Health Industrial Park of Rudong High-tech Zone
    City
    Nantong Jiangsu
    Country
    CN

    Owner / Operator

    Firm Name
    Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
    Operator Number
    10084191
    Address
    No.888, Zhujiang Road, Juegang Street, Rudong County, Life and Health Industrial Park of Rudong High-tech Zone
    City
    Nantong
    State
    Jiangsu
    Postal Code
    226499
    Country
    CN
    Correspondent
    Licheng Liu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR

    Proprietary Names

    Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)

    Establishment Types

    Manufacture Medical Device