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Aurora Future Education Group

Regulatory activities for this sponsor.

Type

Date

1 result(s) found, displaying 1 to 1

  • 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/ Serum/Plasma Combo) (Cancelled from the ARTG under s41GN(1))

    Cancellation or suspension
    Regulatory action due to The sponsor failed to provide information to comply with Essential principles of s41FN(3)(a), failed to provide evidence that device complies with conformity assessment procedures of s41FN(3)(b) and certifications made by the sponsor under section s41FC(2) of the Therapeutic Goods Act 1989 in relation to the inclusion of the kind of device in the ARTG are incorrect in a material particular., effective 16/10/2020

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