BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Chembio HIV 1/2 STAT PAK Assay

    Reg #: 2431980 · FEI: 2431980 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CHEMBIO DIAGNOSTIC SYSTEMS, INC.
    Registration Number
    2431980
    FEI Number
    2431980
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3661 HORSEBLOCK RD.
    City
    MEDFORD
    State
    NY
    ZIP
    11763
    Country
    US

    Regulatory Submissions

    PMA Number
    BP050010

    Owner / Operator

    Firm Name
    CHEMBIO DIAGNOSTIC SYSTEMS, INC.
    Operator Number
    2431980
    Address
    3661 HORSEBLOCK RD., --
    City
    MEDFORD
    State
    NY
    Postal Code
    11763
    Country
    US
    Correspondent
    THOMAS D IPPOLITO

    Products

    Device Name Product Code
    Test, Hiv Detection MZF

    Proprietary Names

    Chembio HIV 1/2 STAT PAK Assay

    Establishment Types

    Manufacture Medical Device