BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CD DIAGNOSTICS, INC

    Reg #: 3011171357 · FEI: 3011171357 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CD DIAGNOSTICS, INC
    Registration Number
    3011171357
    FEI Number
    3011171357
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    650 Naamans Road, Suite 100
    City
    Claymont
    State
    DE
    ZIP
    19703
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN180032

    Owner / Operator

    Firm Name
    CD Diagnostics, Inc
    Operator Number
    10047552
    Address
    650 Naamans Road (Suite 100)
    City
    Claymont
    State
    DE
    Postal Code
    19703
    Country
    US
    Correspondent
    Jay Pathak

    Products

    Device Name Product Code
    Lateral Flow Immunochromatography Assay For Host Infection Biomarkers QGN
    Multiple Osteoarticular Pathogen Antigen Kit QHV
    Test For Periprosthetic Joint Infection PIL

    Proprietary Names

    Synovasure Alpha Defensin Lateral Flow Test Kit Synovasure Alpha Defensin ELISA Test Synovasure Alpha Defensin Control Kit Synovasure Alpha Defensin Lateral Flow Test Kit and Synovasure Alpha Defensin Control Kit

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only