BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ONE STEP PREGNANCY TEST DEVICE (URINE)

    Reg #: 1417592 · FEI: 1417592 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDLINE INDUSTRIES, LP - Northfield
    Registration Number
    1417592
    FEI Number
    1417592
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    Three Lakes Drive
    City
    Northfield
    State
    IL
    ZIP
    60093
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993317

    Owner / Operator

    Firm Name
    Medline Industries, LP
    Operator Number
    1417592
    Address
    Three Lakes Drive
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    Correspondent
    Stephanie Augsburg

    Products

    Device Name Product Code
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    ONE STEP PREGNANCY TEST DEVICE (URINE)

    Establishment Types

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