On Tuesday, QuidelOrtho Corporation (NASDAQ:QDEL) received FDA 510(k) clearance for its QuickVue COVID-19 test.
This clearance allows the test to be used accurately and conveniently in home and medical facility settings with CLIA certificates of waiver.
The QuickVue COVID-19 test, designed for symptomatic individuals within six days of symptom onset, 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.
QuidelOrtho secured FDA 510(k) clearance in December 2023 for its Savanna PCR platform and Savanna HSV 1+2/VZV PCR assay.
This clearance authorizes the marketing and sale of the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to U.S. laboratories conducting moderate or high-complexity diagnostic testing.
However, the shares are plunging as the company said that ...