One Step HCG Urine Pregnancy Test (Cancelled from the ARTG under s.41GN(1)(b) and s.41GN(1))
Product name
One Step HCG Urine Pregnancy Test
ARTG
260088
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN(1)(b) and s.41GN(1)
Grounds for regulatory action
The sponsor did not provide evidence that the Device is safe or performs as intended, nor did the Sponsor provide information to substantiate compliance with the Essential Principles; the sponsor failed to comply with conditions to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a).