BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUANTA Flash ENA7 Reagent Kit

    Reg #: 2026994 · FEI: 2026994 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INOVA DIAGNOSTICS, INC.
    Registration Number
    2026994
    FEI Number
    2026994
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9900 Old Grove Rd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122923

    Owner / Operator

    Firm Name
    INOVA DIAGNOSTICS, INC.
    Operator Number
    2026994
    Address
    9900 OLD GROVE RD., --
    City
    San Diego
    State
    CA
    Postal Code
    92131
    Country
    US
    Correspondent
    Constance Bridges

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Multi-Analyte Mixture JIX
    Extractable Antinuclear Antibody, Antigen And Control LLL

    Proprietary Names

    QUANTA Flash ENA7 Reagent Kit QUANTA Flash ENA7 Calibrators QUANTA Flash ENA7 Controls QUANTA Flash ENA7 Calibrator Kit QUANTA Flash ENA7 Control Kit QUANTA Flash ENA7 Reagents

    Establishment Types

    Manufacture Medical Device