ellume D1012808 G COVID-19 Home Test User Guide

ellume D1012808 G COVID-19 Home Test

Product Information

The product is a COVID-19 home test kit that aids in the clinical diagnosis of COVID-19 infections. The kit includes processing fluid, a nasal swab, a dropper, and an analyzer. The Ellume COVID-19 Home Test App is also required to perform the test. The test is intended for invitro diagnostic use only. Children aged 2-15 must be tested by an adult (18+ years old), and children aged 2-12 must be swabbed with the Child Adapter in place.

Usage Instructions

1. Unbox Components: Only open the foil packaging when you are ready to do the test. Perform the test within 1 hour of opening.
2. Download & Open App: Download the free Ellume COVID-19 Home Test App from the Google Play, the App Store, or visit www.ellumecovidtest.com.
3. Answer a Few Questions in the App: This will select the right video and instructions for you and enable result personalization.
4. Watch Information Video: Get familiar with the test. Do not perform the test during the video.
5. Follow Instructions: The App has step-by-step instructions to guide you through the test after the video.
   • Do’s: Follow the App’s instructions carefully when performing the test. Only use the kit components provided. Keep the Analyzer on a flat surface within 3 feet of your phone until the result is available. If multiple people are testing, connect the Analyzer to your phone and wait 30 seconds before another person connects their Analyzer to their phone.
   • Don’ts: Keep test out of reach of children and pets. Do not use Test if any of the packaging is open or damaged. Do not touch the Swab Tip. Do not add fewer or more drops of the sample fluid than instructed. Do not add the sample fluid to the Analyzer before it is connected. Do not close the App until your result is available. Do not perform the test in unstable (changing) light conditions. The desiccant sachet is not for use in the test.
6. Need Help? Visit ellumecovidtest.com or call 1-888-885-6121.

Regardless of your test result, please consult a healthcare professional if your symptoms persist or become more severe.

QUICK START GUIDE
Refer to the Product Information Leaflet for more complete information.
This test is intended to be used as an aid to the clinical diagnosis of a COVID-19 infection. Do not use this test as the only guide to manage your illness.

DO’S

• Follow the App’s instructions carefully when performing the test.
• Children aged 2-15 must be tested by an adult (18+ years old).
• Children aged 2-12 must be swabbed with the Child Adapter in place.
• Only open kit component packaging when ready to use the test.
• Only use the kit components provided.
• Keep the Analyzer on a flat surface within 3” of your phone until the result is available.
• If multiple people are testing, connect the Analyzer to your phone and wait 30 secs before another person connects their Analyzer to their phone.
• Keep test out of reach of children and pets.

DON’TS

• Do not use Test if any of the packaging is open or damaged.
• Do not touch the Swab Tip.
• Do not add fewer or more drops of the sample fluid than instructed.
• Do not add the sample fluid to the Analyzer before it is connected.
• Do not close the App until your result is available.
• Do not perform the test in unstable (changing) light conditions.
• The desiccant sachet is not for use in the test.

Regardless of your test result, please consult a healthcare professional if your symptoms persist of become more severe.

GETTING STARTED

1. UNBOX COMPONENTS
   • Only open the foil packaging when you are ready to do the test. Perform the test within 1 hour of opening.
2. DOWNLOAD & OPEN APP
   • Download the free Ellume COVID-19 Home Test App from the Google Play, the App Store or visit: www.ellumecovidtest.com
3. ANSWER A FEW QUESTIONS IN THE APP
   • This will select the right video and instructions for you and enable result personalization.
4. WATCH INFORMATION VIDEO
   • Get familiar with the test.
   • Do not perform the test during the video.
5. FOLLOW INSTRUCTIONS
   • The App has step-by-step instructions to guide you through the test after the video.

In the USA, 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.

Need help? Visit ellumecovidtest.com or call 1-888-885-6121

Ellume Limited 57 Didsbury St, East Brisbane, Qld 4169, Australia
For invitro diagnostic use. No test component to be used inside the body except the Nasal Swab as directed.

References

• Home - ellume
• Home | Ellume COVID-19 Home Test
• Coronavirus Disease 2019 (COVID-19) | CDC
• Coronavirus Disease 2019 (COVID-19) | CDC
• Home | Ellume COVID-19 Home Test
• Resources | Ellume COVID-19 Home Test
• COVID-19 Treatments | HHS/ASPR
• Centers for Disease Control and Prevention | CDC
• cdc.gov/coronavirus
• Home | Ellume COVID-19 Home Test
• 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222

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