BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCU NEWS One Step hCG Pregnancy Test Cassette

    Reg #: 3022137053 · FEI: 3022137053 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CorDx Inc.
    Registration Number
    3022137053
    FEI Number
    3022137053
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3719 North Peachtree Road, Suite 200
    City
    Chamblee
    State
    GA
    ZIP
    30341
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150063

    Owner / Operator

    Firm Name
    CorDx
    Operator Number
    10050914
    Address
    9540 Waples St Unit C
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Amber Wen

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    ACCU NEWS One Step hCG Pregnancy Test Cassette ACCU NEWS Pregnancy Test Midstream ACCU NEWS Pregnancy Test Strip ACCU NEWS Pregnancy Test Cassette ACCU NEWS One Step hCG Pregnancy Test Midstream ACCU NEWS Ovulation Test + Pregnancy Test Combo ACCU NEWS One Step hCG Pregnancy Test Strip CorDx Tyfast Pregnancy Test Cassette CorDx Tyfast Pregnancy Test Strip CorDx Tyfast Pregnancy Test Midstream

    Establishment Types

    Manufacture Medical Device