BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOWDIAGNOSTICS, INC.

    Reg #: 3010864358 · FEI: 3010864358 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    NOWDIAGNOSTICS, INC.
    Registration Number
    3010864358
    FEI Number
    3010864358
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1200 STEWART PL
    City
    Springdale
    State
    AR
    ZIP
    72764
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033297

    Owner / Operator

    Firm Name
    Now Diagnostics, Inc.
    Operator Number
    10048184
    Address
    1200 Stewart Place
    City
    Springdale
    State
    AR
    Postal Code
    72764
    Country
    US
    Correspondent
    Amairani P Lester

    Products

    Device Name Product Code
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users SBZ

    Proprietary Names

    ADEXUSDx First to Know Pregnancy Test ADEXUSDx Syphilis controls ADEXUSDx hCG controls First to Know Syphilis Test

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198