(RTTNews) - QuidelOrtho (QDEL) said it has received FDA 510(k) clearance for QuickVue COVID-19 test. The clearance allows the test to be used in home and medical facility settings with CLIA certificates of waiver. The QuickVue test is cleared for use in individuals aged 14 or older when self-testing, and in those aged two and older when administered by an adult.
The company noted that symptomatic individuals receiving an initial negative result must undergo re-testing between 48 and 72 hours later, using either an antigen or molecular test for SARS-CoV-2.
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