QuickVue One-Step hCG urine test kit (Suspended from the ARTG under s.41GA(1)(b))
Product name
QuickVue One-Step hCG urine test kit
ARTG
199827
Date action takes effect
Compliance action
Medical device suspension
Type of action
Suspended from the ARTG under s.41GA(1)(b)
Grounds for regulatory action
I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15.