BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Specific Diagnostics

    Reg #: 3023036790 · FEI: 3023036790 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    Specific Diagnostics
    Registration Number
    3023036790
    FEI Number
    3023036790
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    130 Baytech Dr
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230675

    Owner / Operator

    Firm Name
    BIOMERIEUX SA
    Operator Number
    8020790
    Address
    Chemin De L Orme
    City
    Marcy L Etoile
    State
    Rhone
    Postal Code
    69280
    Country
    FR

    Products

    Device Name Product Code
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation LON
    Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples SAN

    Proprietary Names

    VITEK REVEAL GN01-AST VITEK REVEAL Sealer VITEK REVEAL Sensor Panel VITEK REVEAL BC GN02-AST VITEK REVEAL

    Establishment Types

    Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device