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    FDA Registration Active 🇺🇸 United States

    60-MA1748 Pointe Multi-Analyte Set D Urine DAU Intermediate Calibrator

    Reg #: 1827821 · FEI: 1827821 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HORIBA INSTRUMENTS INCORPORATED
    Registration Number
    1827821
    FEI Number
    1827821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5449 RESEARCH DRIVE
    City
    Canton Twp
    State
    MI
    ZIP
    48188
    Country
    US

    Owner / Operator

    Firm Name
    HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
    Operator Number
    10083022
    Address
    9755 Research Drive
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Calibrators, Drug Mixture DKB

    Proprietary Names

    60-MA1748 Pointe Multi-Analyte Set D Urine DAU Intermediate Calibrator 60-MA1786 Pointe Multi-Analyte Set E DAU Cutoff Calibrator 60-MA1790 Pointe Multi-Analyte Set E DAU High Calibrator 60-MA1742 Pointe Multi-Analyte Set D Urine DAU Negative Calibrator 60-MA1744 Pointe Multi-Analyte Set D Urine DAU Low Calibrator 60-MA1782 Pointe Multi-Analyte Set E DAU Negative Calibrator 60-MA1788 Pointe Multi-Analyte Set E DAU Intermediate Calibrator 60-MA1784 Pointe Multi-Analyte Set E DAU Low Calibrator 60-MA1746 Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator 60-MA1750 Pointe Multi-Analyte Set D Urine DAU High Calibrator

    Establishment Types

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