BEUDAMED
    FDA Registration Active 🇫🇷 France

    ABX PENTRA HDL DIRECT CP

    Reg #: 3000148879 · FEI: 3000148879 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    HORIBA ABX SAS
    Registration Number
    3000148879
    FEI Number
    3000148879
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290
    City
    MONTPELLIER Herault
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K060854

    Owner / Operator

    Firm Name
    HORIBA ABX SAS
    Operator Number
    9036328
    Address
    PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290
    City
    MONTPELLIER
    State
    FR-NOTA
    Postal Code
    34184
    Country
    FR

    US Agent

    Business Name
    HORIBA Instruments Incorporated
    Contact Name
    Will Cripps
    Address
    5449 Research Drive, Canton, MI 48188
    City
    Canton
    State
    MI
    ZIP
    48188
    Country
    US
    Email
    [email protected]
    Phone
    800 4459853

    Products

    Device Name Product Code
    Ldl & Vldl Precipitation, Hdl LBR
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT
    System, Test, Low Density, Lipoprotein MRR

    Proprietary Names

    ABX PENTRA HDL DIRECT CP ABX PENTRA HDL CAL ABX PENTRA LDL DIRECT CP ABX PENTRA TRIGLYCERIDES CP ABX PENTRA LDL CAL ABX PENTRA CHOLESTEROL CP Yumizen C1200 LDL Direct ABX PENTRA HDL DIRECT 100 CP Yumizen C1200 HDL Direct

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device