BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BD MAX Extended Enteric Bacterial Panel with FecalSwab

    Reg #: 1119779 · FEI: 1119779 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    BECTON, DICKINSON & CO.
    Registration Number
    1119779
    FEI Number
    1119779
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7 LOVETON CIR.
    City
    SPARKS
    State
    MD
    ZIP
    21152
    Country
    US

    Regulatory Submissions

    510(k) Number
    K214122

    Owner / Operator

    Firm Name
    Becton Dickinson and Company
    Operator Number
    9922032
    Address
    One Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System PCI
    Real Time Nucleic Acid Amplification System OOI
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH

    Proprietary Names

    BD MAX Extended Enteric Bacterial Panel with FecalSwab BD MAX Enteric Bacterial Panel with FecalSwab

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility