BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Adalimumab Assay

    Reg #: 3026565854 · FEI: 3026565854 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Chembio Diagnostic Systems
    Registration Number
    3026565854
    FEI Number
    3026565854
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1560 Fifth Avenue
    City
    Bay Shore
    State
    NY
    ZIP
    11706
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN220023

    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
    Adalimumab Assay QYD

    Proprietary Names

    Adalimumab Assay

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198