BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    VITROS ApoA1 Reagent

    Reg #: 3012963943 · FEI: 3012963943 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Ortho Clinical Diagnostics, K.K.
    Registration Number
    3012963943
    FEI Number
    3012963943
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    East Tower 16F, GateCilty Osaki, Osaki 1-11-2,, Ortho Care Technical Support Center
    City
    Shinagawa-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K042521

    Owner / Operator

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

    US Agent

    Business Name
    Ortho-Clinical Diagnostics, Inc.
    Contact Name
    Marlene Hanna
    Address
    100 Indigo Creek Drive
    City
    Rochester
    State
    NY
    ZIP
    14626
    Country
    US
    Email
    [email protected]
    Phone
    585 4534041

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Apolipoproteins MSJ

    Proprietary Names

    VITROS ApoA1 Reagent VITROS Calibrator Kit 21 VITROS ApoB Performance Verifiers VITROS ApoA1 Performance Verifiers VITROS Calibrator Kit 22 VITROS ApoB Reagent

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198