BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSOM Strep A Test

    Reg #: 3008776041 · FEI: 3008776041 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SEKISUI DIAGNOSTICS, LLC
    Registration Number
    3008776041
    FEI Number
    3008776041
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    One Wall Street
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K961423

    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

    Products

    Device Name Product Code
    Antisera, All Groups, Streptococcus Spp. GTZ

    Proprietary Names

    OSOM Strep A Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198