BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUANTA Flash aCL IgA Reagents

    Reg #: 2026994 · FEI: 2026994 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    9
    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
    K120817

    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
    System, Test, Anticardiolipin Immunological MID
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV

    Proprietary Names

    QUANTA Flash aCL IgA Reagents QUANTA Flash B2 GP1 IgA QUANTA Flash Cardiolipin IgA Reagents QUANTA Flash Cardiolipin IgA Controls QUANTA Flash Cardiolipin IgA QUANTA Flash aCL IgA QUANTA Flash B2 GP1 IgA Reagents QUANTA Flash B2 GP1 IgA Controls QUANTA Flash aCL IgA Controls

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility