BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VITROS HbA1c Reagent Kit

    Reg #: 1319681 · FEI: 1000136573 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Registration Number
    1319681
    FEI Number
    1000136573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Indigo Creek Dr
    City
    Rochester
    State
    NY
    ZIP
    14626
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142595

    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
    Hemoglobin A1c Test System PDJ
    Calibrator, Secondary JIT
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    VITROS HbA1c Reagent Kit VITROS Percent A1c Performance Verifiers VITROS Calibrator Kit 31

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility