BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    GENETIC SIGNATURES LIMITED

    Reg #: 3011781554 · FEI: 3011781554 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    GENETIC SIGNATURES LIMITED
    Registration Number
    3011781554
    FEI Number
    3011781554
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7 Eliza St
    City
    Newtown New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K232672

    Owner / Operator

    Firm Name
    Genetic Signatures Limited
    Operator Number
    10049463
    Address
    7 Eliza St
    City
    Newtown, Sydney
    State
    New South Wales
    Postal Code
    2042
    Country
    AU

    US Agent

    Business Name
    Genetic Signatures US Ltd
    Contact Name
    Mike Aicher
    Address
    1124 W Carson St MRL, 1124 W Carson St Building, 3rd FL
    City
    Torrance
    State
    CA
    ZIP
    90502
    Country
    US
    Email
    [email protected]
    Phone
    310 3867863

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU
    Clinical Sample Concentrator JJH
    Real Time Nucleic Acid Amplification System OOI
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH

    Proprietary Names

    3base™ ASRs EasyScreen™ Sample Processing Kit SP001 EasyScreen™ Sample Processing Kit SP005 EasyScreen™ Sample Processing Kit SP012 EasyScreen™ Sample Processing Kit SP008 EasyScreen™ Sample Processing Kit SP006 EasyScreen™ Sample Processing Kit SP008v2 EasyScreen Gastrointestinal Parasite Detection Kit

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198