2019-nCov Ab Test (Colloidal Gold) (Cancelled from the ARTG under s.41GN(1)(b))
Product name
2019-nCov Ab Test (Colloidal Gold)
Sponsor
ARTG
333090
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN(1)(b)
Grounds for regulatory action
The certifications made by the sponsor under section 41FD 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 and the sponsor failed to comply with the conditions of inclusion stipulated under paragraph 41FN.