BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Positive Control HSV/VZV/TP

    Reg #: 3012113276 · FEI: 3012113276 · Expires 2025
    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
    2025
    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 Positive Control Flu/RSV/SARS ResistancePlus GC Control ResistancePlus MG Positive Control

    Establishment Types

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