BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSOM COVID-19 Antigen Control Kit

    Reg #: 2030538 · FEI: 1000520007 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Sekisui Diagnostics, LLC
    Registration Number
    2030538
    FEI Number
    1000520007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6659 Top Gun St
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    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
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

    OSOM COVID-19 Antigen Control Kit OSOM COVID-19 Antigen Home Test OSOM Flu SARS-CoV-2 Combo Test OSOM Flu SARS-CoV-2 Combo Control Kit COVID-19 Antigen Home Test OSOM COVID-19 Antigen Rapid Test OSOM FLU Home Test OSOM Flu SARS-CoV-2 Combo Home Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device