BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)

    Reg #: 1050190 · FEI: 1050190 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CENTERS FOR DISEASE CONTROL AND PREVENTION
    Registration Number
    1050190
    FEI Number
    1050190
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1600 CLIFTON RD., N.E.
    City
    ATLANTA
    State
    GA
    ZIP
    30333
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243931

    Owner / Operator

    Firm Name
    U.S. GOVERNMENT DEPARTMENT HHS
    Operator Number
    1050190
    Address
    1600 CLIFTON RD., N.E.
    City
    ATL
    State
    GA
    Postal Code
    30329
    Country
    US
    Correspondent
    DR. DENNIS A BAGAROZZI JR.

    Products

    Device Name Product Code
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE

    Proprietary Names

    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) Influenza A Subtyping Kit (VER 4) Influenza A/H5 Subtyping Kit (VER 4) Influenza B Lineage Genotyping Kit (VER 1.1 and 2)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device