The BARDA funding is for the validation and submission of the Simplexa Covid-19 Direct kit and the Simplexa Covid-19 & Flu A/B Direct kit for FDA 510(k) clearance.
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Aim Lab covid-19 PathFinder benchtop automation solutions can help overcome many covid-19-related challenges.
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Ortho Clinical Diagnostics’ Vitros SARS-CoV-2 Antigen Test has become the first high-volume covid-19 antigen test to receive FDA emergency use authorization.
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QuantuMDx expects to achieve CE-IVD marking for its Q-POC system in early 2021, following a release for research use only.
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Independently validated early results have proven 100% in specificity after testing 280 samples and 100% sensitivity by testing 260 samples of recovered and symptomatic patients.
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