- Test for both symptomatic and asymptomatic COVID-19
- Detects all known COVID-19 Variants
- NAVICA app for digital instructions and results reporting.
- Authorized for use from ages 2 and up.
- 2 Tests Per Kit to allow follow up 24 hours after the first test.
- Visual results available in 15 minutes
Two (2) test cards
Two (2) extraction reagent
Two (2) nasal swabs
Patient instructions for Use
Individual Fact Sheet
- 84.6% Sensitivity
- 98.5% Specificity
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. 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.
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