Respiratory Test Kit QuickVue® COVID-19 Test 2 Tests CLIA Waived

Features

• QuickVue At-Home OTC COVID-19 Test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under the new name – QuickVue COVID-19 Test
• The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset
• This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older
• The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2
• All negative results are presumptive
• Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment
• Positive results do not rule out co-infection with other respiratory pathogens

More Information

• QuickVue COVID-19 Test 510k IFU
• QuickVue COVID-19 Test 510k Healthcare Providers IFU
• QuickVue COVID-19 Test 510k Quick Ref