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LumiraDx Gets CE Marking For New SARS-CoV-2 And Flu A/B Antigen Test Kit

LumiraDx (LMDX), a diagnostics company said on Thursday that its latest SARS-CoV-2 & Flu A/B Antigen Test has bagged CE Marking, the European Union's mandatory conformity marking system to regulate the goods sold within the EU region.

"The microfluidic immunofluorescence assay can quickly verify potential infection for patients suspected of influenza and/or Covid-19, helping to identify and differentiate the underlying cause of respiratory illness and to inform treatment decisions at the point of care," the company said in a statement.

The assay yields test results in 12 minutes or less from samples collected, thereby supporting quick clinical decision-making at point of care (POC), which is expected to prevent the further spread of infection.

Shipments of the LumiraDx SARS-CoV-2 & Flu A/B Antigen Test kits are expected to begin shortly.

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