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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 details
- 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.