BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    SPEEDX PTY LTD

    Reg #: 3012113276 · FEI: 3012113276 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SPEEDX PTY LTD
    Registration Number
    3012113276
    FEI Number
    3012113276
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Suite 102, National Innovation Centre, 4 Cornwallis Street
    City
    Eveleigh New South Wales
    Country
    AU

    Owner / Operator

    Firm Name
    SpeeDx Pty Ltd
    Operator Number
    10057454
    Address
    Suite 102, National Innovation Centre, 4 Cornwallis Street
    City
    Eveleigh
    State
    New South Wales
    Postal Code
    2015
    Country
    AU

    US Agent

    Business Name
    SpeeDx Inc.
    Contact Name
    Jeremy Stackawitz
    Address
    5900 Balcones Dr # 25820
    City
    Austin
    State
    TX
    ZIP
    78731
    Country
    US
    Email
    [email protected]
    Phone
    215 4329629

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Positive Control HSV/VZV/TP ResistancePlus MG Positive Control Positive Control Flu/RSV/SARS ResistancePlus GC Control

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device