BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUANTA Flash Sm Reagents

    Reg #: 2026994 · FEI: 2026994 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    4

    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
    K123593

    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
    Anti-Sm Antibody, Antigen And Control LKP
    Anti-Rnp Antibody, Antigen And Control LKO
    Calibrator, Secondary JIT

    Proprietary Names

    QUANTA Flash Sm Reagents QUANTA Flash RNP Reagents QUANTA Flash Sm Controls QUANTA Flash RNP Controls QUANTA Flash RNP Calibrators QUANTA Flash Sm Calibrators

    Establishment Types

    Manufacture Medical Device