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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit (Cancellation from the ARTG under subsection 41GM(1) of the Act)
Product name
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit
Sponsor
ARTG details
- 385370
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GM(1) of the Act.
Grounds for regulatory action
Failure to respond with information requested under s41JA to provide evidence to demonstrate that the Device complies with the applicable provisions of the Act and the Regulations.