BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Extractable Antinuclear Antibody (ENA) Screening Kit, SS-B

    Reg #: 1181055 · FEI: 1181055 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HEMAGEN DIAGNOSTICS, INC.
    Registration Number
    1181055
    FEI Number
    1181055
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2900 LOCH RAVEN RD
    City
    Baltimore
    State
    MD
    ZIP
    21218
    Country
    US

    Regulatory Submissions

    510(k) Number
    K946120

    Owner / Operator

    Firm Name
    HEMAGEN DIAGNOSTICS, INC.
    Operator Number
    1221107
    Address
    2900 LOCH RAVEN RD, --
    City
    Baltimore
    State
    MD
    Postal Code
    21218
    Country
    US

    Products

    Device Name Product Code
    Extractable Antinuclear Antibody, Antigen And Control LLL

    Proprietary Names

    Extractable Antinuclear Antibody (ENA) Screening Kit, SS-B

    Establishment Types

    Manufacture Medical Device