BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MESACUP BP180 ELISA Kit and MESACUP BP230 ELISA Kit

    Reg #: 3003155207 · FEI: 3003155207 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory
    Registration Number
    3003155207
    FEI Number
    3003155207
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1018-1 Terasawaoka
    City
    INA Nagano
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K071961

    Owner / Operator

    Firm Name
    MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. Ina Laboratory
    Operator Number
    9039476
    Address
    SUMITOMO FUDOSAN SHIBADAIMON NICHOME BLDG., 2-11-8 Shibadaimon
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    105-0012
    Country
    JP

    US Agent

    Business Name
    Bion Enterprises, Ltd.
    Contact Name
    Nadine Shabat
    Address
    455 State St Ste 100
    City
    Des Plaines
    State
    IL
    ZIP
    60016
    Country
    US
    Email
    [email protected]
    Phone
    847 5445044 ext. 2149

    Products

    Device Name Product Code
    Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 OEG

    Proprietary Names

    MESACUP BP180 ELISA Kit and MESACUP BP230 ELISA Kit

    Establishment Types

    Manufacture Medical Device