CovClear COVID-19 Antigen Test/ CT772 (Suspension from the ARTG under section 41GA of the Act.)
Product name
CovClear COVID-19 Antigen Test/ CT772
Sponsor
ARTG
374063
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspension from the ARTG under section 41GA of the Act.
Grounds for regulatory action
Under subsection 41GA(1)(a); there is a potential risk of death, serious illness or serious injury if the kind of device continues to be included in the Register; and it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the kind of device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register