BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gastrointestinal Pathogen Panel (GPP) Kit

    Reg #: 3007799234 · FEI: 3007799234 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Applied BioCode, Inc.
    Registration Number
    3007799234
    FEI Number
    3007799234
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12130 Mora Drive Unit #2
    City
    Santa Fe Springs
    State
    CA
    ZIP
    90670
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180041

    Owner / Operator

    Firm Name
    Applied BioCode, Inc.
    Operator Number
    10029149
    Address
    12130 Mora Drive Unit #2, 10370 Slusher Drive Unit #2-7
    City
    Santa Fe Springs
    State
    CA
    Postal Code
    90670
    Country
    US
    Correspondent
    Raja Krishnamurti

    Products

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

    Proprietary Names

    Gastrointestinal Pathogen Panel (GPP) Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device