BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENZYME IMMUNOASSAY ANTINUCLEA

    Reg #: 2915274 · FEI: 2915274 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Bio-Rad Laboratories, Inc.
    Registration Number
    2915274
    FEI Number
    2915274
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4000 Alfred Nobel Drive
    City
    Hercules
    State
    CA
    ZIP
    94547
    Country
    US

    Regulatory Submissions

    510(k) Number
    K954723

    Owner / Operator

    Firm Name
    Bio-Rad Laboratories, Inc.
    Operator Number
    9929003
    Address
    4000 Alfred Nobel Drive, --
    City
    Hercules
    State
    CA
    Postal Code
    94547
    Country
    US

    Products

    Device Name Product Code
    Antinuclear Antibody, Antigen, Control LKJ

    Proprietary Names

    ENZYME IMMUNOASSAY ANTINUCLEA Autoimmune EIA ANA Screening Test Kit (96 Test) Trinity EIA ANA Screen Test Kit Meridian EIA ANA Screen Test Kit DiaSorin EIA ANA Screen Test Kit Quest EIA ANA Screen Test Kit Autoimmune EIA ANA Screening Test Kit (576 Test)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device