BEUDAMED
    FDA Registration Active 🇫🇷 France

    PENTRA C400 STD

    Reg #: 3000148879 · FEI: 3000148879 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    7

    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
    K052007

    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
    Hexokinase, Glucose CFR
    Electrode, Ion-Specific, Chloride CGZ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion Specific, Potassium CEM
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Electrode, Ion Specific, Sodium JGS
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    PENTRA C400 STD ABX PENTRA GLUCOSE PAP CP ABX PENTRA CLEAN-CHEM CP CUVETTE SEGMENTS RACK ABX PENTRA CLEAN-CHEM 99 CP ABX PENTRA ETCHING CP ABX PENTRA POTASSIUM-E ABX PENTRA SODIUM-E I.S.E. MODULE SAMPLE CUP - YELLOW ABX PENTRA REFERENCE ABX PENTRA GLUCOSE HK CP SAMPLE CUP - WHITE ABX PENTRA STANDARD 1 ABX PENTRA MULTICAL SAMPLE CUP - BLUE SAMPLE CUP - GREEN ABX PENTRA CHLORIDE-E ABX PENTRA DEPROTEINIZER CP ABX PENTRA REFERENCE-E PENTRA C400 ISE ABX PENTRA STANDARD 2 ABX PENTRA REFERENCE 280ml BIOCHEMISTRY SPARE PARTS OR CONSUMABLES

    Establishment Types

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