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    Certificación Australia - Test Rapido Covid - Lungene

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    marvin alvarado
    This document is a certificate from the Australian Register of Therapeutic Goods approving the supply of Severe acute respiratory syndrome-associated coronavirus IVDs. It provides details on the manufacturer, intended purpose of the tests, and conditions for inclusion on the register.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Certificación Australia - Test Rapido Covid - Lungene

    Uploaded by

    marvin alvarado
    10 views2 pages
    This document is a certificate from the Australian Register of Therapeutic Goods approving the supply of Severe acute respiratory syndrome-associated coronavirus IVDs. It provides details on the manufacturer, intended purpose of the tests, and conditions for inclusion on the register.

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    © © All Rights Reserved

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    PDF, TXT or read online from Scribd

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    This document is a certificate from the Australian Register of Therapeutic Goods approving the supply of Severe acute respiratory syndrome-associated coronavirus IVDs. It provides details on the manufacturer, intended purpose of the tests, and conditions for inclusion on the register.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    10 views2 pages

    Certificación Australia - Test Rapido Covid - Lungene

    Uploaded by

    marvin alvarado
    This document is a certificate from the Australian Register of Therapeutic Goods approving the supply of Severe acute respiratory syndrome-associated coronavirus IVDs. It provides details on the manufacturer, intended purpose of the tests, and conditions for inclusion on the register.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 2

    Australian Register of Therapeutic Goods Certificate

    Issued to

    APAC Security Pty Ltd


    for approval to supply

    Severe acute respiratory syndrome-associated coronavirus IVDs


    ARTG Identifier 333341
    ARTG Start date 5/04/2020
    Product Category Medical Device Included - IVD Class 3
    GMDN CT772
    GMDN Term Severe acute respiratory syndrome-associated coronavirus IVDs
    Intended Purpose The COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic
    immunoassay for the qualitative detection of antibodies(IgG and IgM) to
    Novel coronavirus in human Whole Blood/Serum/Plasma
    Manufacturer Details Address Certificate number(s)
    Hangzhou Clongene Biotech Co Ltd No 1 Yichuang Road Yuhang DV-2020-MC-04126-1
    Sub district
    Yuhang District, Hangzhou,
    311121
    China
    ARTG Standard Conditions
    The above Medical Device Included - IVD Class 3 has been entered on the Register subject to the
    following conditions:
    · - The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or
    imposed on the ARTG entry. Refer Part 4-5, Division 2 (Conditions) of the Therapeutic Goods Act 1989
    and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for
    relevant information.
    - Breaching conditions of the inclusion related to the device of the kind may lead to suspension or
    cancellation of the ARTG entry; may be a criminal offence; and civil penalties may apply.
    Products Covered by This Entry
    1. Severe acute respiratory syndrome-associated coronavirus IVDs
    This entry: containsSystem(s)/Procedure Pack(s)
    IVD Information
    Name Category Description
    COVID-19 Point of care testing
    IgG/IgM Rapid
    Test Cassette
    Product Specific Conditions
    · 1.The person (the sponsor) in relation to whom the Device is included in the ARTG may only supply
    the Device to a.laboratories that are accredited pathology laboratories and/or b.medical
    practitioners who are registered under a law of a State or Territory and/or c.health care professionals
    in residential and aged care facilities and/or d.Commonwealth, State or Territory department of
    health and/or e.an agency of the Commonwealth, State or Territory acting on behalf of
    Commonwealth, State or Territory department of health. And within 12 months of an approval the
    following information will be required to be provided to the TGA 2.A report of any adverse events,
    corrective and preventative actions, and customer complaints provided in the context of the number of
    devices supplied since the introduction of the Device(s) to market in Australia and Worldwide.
    3.Information regarding any refusals by Regulatory Authorities for the supply of the Device(s) in any
    other regulatory jurisdictions. 4.Further analytical and clinical evidence to support a.Analytical and
    clinical performance of the device b.Device stability (e.g, shelf-life stability, transport stability)
    5.Instructions for use that provide updated information on the analytical and clinical performance
    characteristics of the device. 6.Evidence of how the user may verify, at the time of use that the
    device will perform as intended by the manufacturer through the use of controls.

    Therapeutic Goods Administration ARTG Identifier: 333341


    PO Box 100, Woden ACT 2606 Australia ARTG Start Date: 5/04/2020
    Phone: 1800 020 653
    Email: [email protected]

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