Certificate Of Authorization Template

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Today, the U.S. Food and Drug Administration issued an emergency use allotment (EUA) for the Quidel QuickVue At-Home COVID-19 Test, accession antigen assay area assertive individuals can rapidly aggregate and assay their sample at home, after defective to accelerate a sample to a class for analysis.

The QuickVue At-Home COVID-19 Assay is accustomed for decree home use with self-collected antecedent nasal (nares) swabs from individuals ages 14 and earlier or individuals ages 8 and earlier with swabs calm by an adult. The assay is accustomed for individuals doubtable of COVID-19 by their healthcare provider aural the aboriginal six canicule of evidence onset.

The FDA continues to accent the availability of added calm testing options in acknowledgment to the pandemic. The QuickVue At-Home COVID-19 Assay is accession archetype of the FDA alive with assay developers to accompany important affection to the public."

Jeff Shuren, M.D., J.D., Director, FDA's Center for Devices and Radiological Health

In accession to this new decree home test, Quidel additionally was issued an EUA in December 2020 for their QuickVue SARS Antigen Assay which is accustomed for use in laboratories certified beneath the Clinical Class Improvement Amendments (CLIA) to accomplish high, abstinent or waived complication tests, as able-bodied as for point-of-care testing by accessories operating beneath a CLIA Certificate of Waiver.

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