QuickVue At-Home OTC COVID-19 2 Test Kits
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Works for symptomatic and asymptomatic individuals.
The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.
Ages 2 and up.
Positive results indicate the presence of viral foreign agent, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status.
How To Use: Four Easy Steps
1. Swab-Collect a gentle nasal swab sample
2. Swirl-After adding the swab to the solution tube
3. Dip-Put the strip into the tube
4. Read Results-Straightforward and easy to read results