BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VITROS Calibrator Kit 16

    Reg #: 1319808 · FEI: 1000305841 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Registration Number
    1319808
    FEI Number
    1000305841
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1000 LEE RD.
    City
    Rochester
    State
    NY
    ZIP
    14606
    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
    Calibrator, Secondary JIT

    Proprietary Names

    VITROS Calibrator Kit 16 VITROS Immunodiagnostic Products CA 19-9 Calibrator VITROS Calibrator Kit 27

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device