BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    PAXgene® Blood RNA System

    Reg #: 3005202328 · FEI: 3005202328 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PREANALYTIX GMBH
    Registration Number
    3005202328
    FEI Number
    3005202328
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Garstligweg 8
    City
    HOMBRECHTIKON Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K082150

    Owner / Operator

    Firm Name
    PREANALYTIX GMBH
    Operator Number
    9073981
    Address
    7 Loveton Circle
    City
    Sparks
    State
    MD
    Postal Code
    21152
    Country
    US

    US Agent

    Business Name
    BECTON DICKINSON AND COMPANY
    Contact Name
    Nathan Carrington
    Address
    1 Becton Dr
    City
    Franklin Lakes
    State
    NJ
    ZIP
    07417
    Country
    US
    Email
    [email protected]
    Phone
    317 6455190

    Products

    Device Name Product Code
    System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test NTW

    Proprietary Names

    PAXgene® Blood RNA System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility