BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    AST/GOT 400T cobas c 111

    Reg #: 3003795116 · FEI: 3003795116 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS INTERNATIONAL LTD.
    Registration Number
    3003795116
    FEI Number
    3003795116
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FORRENSTRASSE 2
    City
    ROTKREUZ Zug
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K071211

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Hexokinase, Glucose CFR
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    System, Test, C-Reactive Protein DCN
    Electrode, Ion-Specific, Chloride CGZ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    AST/GOT 400T cobas c 111 CRP HS 100T cobas c111 Glucose 400T cobas c 111 Glucose HK ISE CHLORID ELEKTR. cobas c 111 system Aspartate Aminotransferase (AST)(S GOT) ISE REFERENCE SOL. cobas c 111 system ISE POTASSIUM ELECTR. cobas c 111 system cobas C (111) AST cobas C (111) GLUCOSE cobas C (111) SODIUM ELECTRODE ISE ISE SODIUM ELECTR. cobas c 111 system ISE Sodium Electrode ISE Potassium Electrode cobas C (111) POTASSIUM ELECTRODE ISE cobas C (111) CHLORIDE ELECTRODE ISE ISE CALIB. IND./URINE cobas c 111 system ISE CALIBRATION KIT cobas c 111 system ASTPM, 740Tests, cobas c 701 C-Reactive Protein cobas c 70X AST/740 ISE Chloride Electrode COBAS C 111 ANALYZER

    Establishment Types

    Manufacture Medical Device