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    FDA Registration Active 🇺🇸 United States

    Quidel Molecular Parainfluenza Virus Control Set (M115)

    Reg #: 1528450 · FEI: 1000122536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Ortho-Clinical Diagnostics, Inc.
    Registration Number
    1528450
    FEI Number
    1000122536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2005 East State Street, Suite 100
    City
    ATHENS
    State
    OH
    ZIP
    45701
    Country
    US

    Owner / Operator

    Firm Name
    QuidelOrtho Corp.
    Operator Number
    2024674
    Address
    9975 Summers Ridge Road, --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    Products

    Device Name Product Code
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    Quidel Molecular Parainfluenza Virus Control Set (M115) VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) Quidel Molecular Strep A+G Control Set (M111) Solana RSV+hMPV Control Set (M123) Quidel Molecular C. difficile Control Set (M108) VITROS HIV Combo Controls (Anti-HIV-1 group O) Solana Influenza A+B Control Set (M122) Quidel Molecular RSV+hMPV Control Set (M107) Quidel Molecular HSV 1+2/VZV Control Set (M121) VITROS HIV Combo Controls (HIV p24 Antigen) Quidel Molecular Influenza A+B Control Set (M106) Quidel Molecular Adenovirus Control Set (M110) VITROS Anti-HIV 1+2 Controls Solana HSV 1+2/VZV Control Set (M118) Quidel Molecular GBS Control Set (M116) QuickVue COVID-19 Test Control Swab Set Quidel Molecular Trichomonas Control Set (M119) Quidel Molecular HSV 1+2 Control Set (M109) Quidel Molecular Bordetella Control Set (M117)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device