BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CHEMBIO DIAGNOSTIC SYSTEMS, INC.

    Reg #: 2431980 · FEI: 2431980 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    17
    Establishment Types
    3
    Classifications
    17

    Registration Details

    Registration Name
    CHEMBIO DIAGNOSTIC SYSTEMS, INC.
    Registration Number
    2431980
    FEI Number
    2431980
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3661 HORSEBLOCK RD.
    City
    MEDFORD
    State
    NY
    ZIP
    11763
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201256
    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
    Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid POG
    Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies NWY
    Enzyme Linked Immunosorbent Assay, T. Cruzi MIU
    Dengue Serological Reagents OSU
    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex MWA
    Test, Hiv Detection MZF
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP
    Coronavirus Antigen Detection Test System. QKP
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Zika Virus Serological Reagents QFO
    Assayed Quality Control Material For Clinical Microbiology Assays QCH
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Reagent, Coronavirus Serological QKO
    Adalimumab Assay QYD
    Infliximab Test System QXT
    Kit, Test, Saliva, Hiv-1&2 MWB

    Proprietary Names

    DPP Ebola Antigen System DPP® Dengue IgM/IgG Assay DPP® Dengue NS1 Antigen Assay TB STAT PAK II DPP HIV-Syphilis Chembio HIV 1/2 STAT PAK Assay Test, HIV detection SURE CHECK HIV 1/2 Assay DPP HIV 1/2 Assay C-Reactive Protein, Antigen, Antiserum and Control DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader Adalimumab Assay Infliximab Test System HIV STAT PAK HIV SURE CHECK HIV DIPSTICK DPP HIV

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198