Ellume Covid-19 Home Test
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Directions
Do Use: As an aid in the diagnosis of current Covid-19 infection. If you are concerned that you have Covid-19. With or without symptoms. Do Not Use: On anyone under 2 years of age. If you are prone to nosebleeds. If you have had a facial or head injury/surgery in the last 6 months. To use this test, you will need to: Download the free Ellume Covid-19 Home Test App. Open the App and carefully follow the instructions on your smartphone. Store in a dry location between 36 - 86 degrees F (2 - 30 degrees C).
Product Details
Test Components: Processing fluid; Dropper; Child adapter, Nasal swab; Analyzer. FDA emergency use authorization. Suitable for ages 2+ years. Results in 15 mins. For use with or without symptoms. Your test is positive for Covid-19. 1x single use test. Phone not included. Why test for Covid-19? Determine if you need to self-isolate. Support decisions about your care. Protect others from Covid-19 infection. This test does not determine if you had Covid-19 in the past or if you have immunity. It detects proteins from the SARS-CoV-2 virus. Bluetooth compatible with most iPhones and Androids. The Ellume Covid-19 Home Test Correctly Identified: 96% of positive samples and 100% of negative samples in individuals with symptoms. 91% of positive samples and 96% of negative samples in individuals without symptoms. This performance was measured during a clinical study conducted in the USA from October 2020 to November 2020, comparing the Ellume Covid-19 Home Test results to a FDA Emergency Use Authorized high sensitivity PCR (molecular) test. No test component to be used inside the body except the Nasal Swab as directed. In USA - For use under an Emergency Use Authorization (EUA) only. FCC listed. ellumecovidtest.com. ellume.com. Scan to check if your smartphone is compatible or visit ellumecovidtest.com. Need help? Visit ellumecovidtest.com or call 1-888-885-6121. In USA - This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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. Made in USA.Nutrition Facts
Warnings
Keep out of reach of children.Manufacturer
Ellume Limited
57 Didsbury St East Brisbane, Qld 4169 Australia
UPC
09356964000008