Severe acute respiratory syndrome-associated coronavirus IVDs (Cancellation from the ARTG under s41GN(1))
Product name
Severe acute respiratory syndrome-associated coronavirus IVDs
Sponsor
ARTG
335597
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under s41GN(1)
Grounds for regulatory action
The sponsor failed to demonstrate that the Device complies with Essential Principles 1,3,6,13, 14 and 15.