BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

    Reg #: 2431980 · FEI: 2431980 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    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

    510(k) Number
    K200506

    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
    Zika Virus Serological Reagents QFO
    Assayed Quality Control Material For Clinical Microbiology Assays QCH
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ

    Proprietary Names

    DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device