Applied BioCode Obtains Emergency Use Authorization for CoV-2 Flu Plus Assay
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Donnerstag, Dezember 16, 2021
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Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for its BioCode CoV-2 Flu Plus Assay.
Key Points:
- Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for its BioCode CoV-2 Flu Plus Assay.
- The BioCode CoV-2 Flu Plus Assay is Applied BioCodes third EUA authorization from the US FDA for COVID-19 testing.
- Applied BioCode previously received FDA EUA authorization for the BioCode SARS CoV-2 Assay and for pooling of up to 5 samples for that assay.
- BioCode CoV-2 Flu Plus Assay builds on the existing portfolio of high-throughput syndromic assays from Applied BioCode including the FDA 510(k) cleared BioCode Respiratory Pathogen Panel (17 targets), FDA 510(k) cleared BioCode Gastrointestinal Pathogen Panel (17 targets), and its stand-alone EUA authorized BioCode SARS-CoV-2 Assay.