Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)-ICOV421 (Cancelled from the ARTG under s.41GN(1)(b))
Product name
COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)-ICOV421
Sponsor
ARTG
333881
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN(1)(b)
Grounds for regulatory action
The sponsor failed to fully comply with a request for information under s41JA and therefore failed to comply with a condition of inclusion under subsection 41FN(2) of the Act.