Molecular diagnostics company
The certificate allows the company's distributor to supply the Class 3 IVD to the Australian market.
Currently, the company's CE-marked and FDA EUA Co-Diagnostics Logix Smart COVID-19 test is available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) and is authorized to be used for the diagnosis of SARS-CoV-2 in the US and other countries.
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