2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/ Serum/Plasma Combo) (Cancelled from the ARTG under s41GN(1))
Product name
2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/ Serum/Plasma Combo)
Sponsor
ARTG
333901
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s41GN(1)
Grounds for regulatory action
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.