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NEW YORK (GenomeWeb) – Mesa Biotech announced today it has received 510(k) clearance and CLIA waiver from the US Food and Drug Administration for a test to detect and distinguish influenza A and B from nasal swab specimens.
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The COVID-19 pandemic created a paradigm shift in modern healthcare, where regulations, protocols, and mindsets had to be reworked in just a matter of months to keep up with the pace of the virus.