BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Sekisui Diagnostics P.E.I. Inc.

    Reg #: 8020316 · FEI: 3002806809 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Sekisui Diagnostics P.E.I. Inc.
    Registration Number
    8020316
    FEI Number
    3002806809
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    70 Watts Avenue
    City
    CHARLOTTETOWN Prince Edward Island
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K113389

    Owner / Operator

    Firm Name
    Sekisui Diagnostics, LLC
    Operator Number
    10035388
    Address
    6659 Top Gun Street
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    US Agent

    Business Name
    Sekisui Diagnostics, LLC
    Contact Name
    Jason Bilobram
    Address
    One Wall Street
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US
    Email
    [email protected]
    Phone
    781 6527848

    Products

    Device Name Product Code
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Acid, Uric, Uricase (Colorimetric) KNK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)