BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ID-FISH Plasmodium faliciparum and P. vivax Combo Test Kit

    Reg #: 3010033384 · FEI: 3010033384 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ID-FISH TECHNOLOGY, INC
    Registration Number
    3010033384
    FEI Number
    3010033384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    556 Gibraltar Drive
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN160025

    Owner / Operator

    Firm Name
    ID-FISH Technology, Inc
    Operator Number
    10042778
    Address
    556 Gibraltar Drive
    City
    Milpitas
    State
    CA
    Postal Code
    95035
    Country
    US
    Correspondent
    Sudhir Shah

    Products

    Device Name Product Code
    Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. PYN

    Proprietary Names

    ID-FISH Plasmodium faliciparum and P. vivax Combo Test Kit ID-FISH Plasmodium Genus Test Kit

    Establishment Types

    Manufacture Medical Device