Urine test strip, multiple constituent (Cancelled from the ARTG under s41GN(1)(f))
Product name
Urine test strip, multiple constituent
Sponsor
ARTG
201378
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s41GN(1)(f)
Grounds for regulatory action
As the sponsor did not provide sufficient information to substantiate that the kind of device was correctly classified, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the Register were correct, in a material particular.