BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VITROS ApoA1 Reagent

    Reg #: 2250051 · FEI: 2250051 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Registration Number
    2250051
    FEI Number
    2250051
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1001 US Highway 202
    City
    RARITAN
    State
    NJ
    ZIP
    08869
    Country
    US

    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

    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