BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PGDx elio tissue complete

    Reg #: 3011805506 · FEI: 3011805506 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PERSONAL GENOME DIAGNOSTICS INC.
    Registration Number
    3011805506
    FEI Number
    3011805506
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3600 Boston Street
    City
    Baltimore
    State
    MD
    ZIP
    21224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192063

    Owner / Operator

    Firm Name
    Personal Genome Diagnostics
    Operator Number
    10059661
    Address
    3600 Boston Street
    City
    Baltimore
    State
    MD
    Postal Code
    21224
    Country
    US
    Correspondent
    Jennifer Dickey

    Products

    Device Name Product Code
    Next Generation Sequencing Based Tumor Profiling Test PZM

    Proprietary Names

    PGDx elio tissue complete

    Establishment Types

    Manufacture Medical Device