ellume COVID-19 Home Test User Guide

: June 6, 2024
: Ellume

Table of Contents

GETTING STARTED
THE COLOR OF COMPONENTS MAY VARY
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ellume
COVID 19 Home Test D1013515A
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 in-app instructions when performing the test.
Keep your phone within 3 inches of the Analyzer until the test result is available.
Keep the Analyzer on a flat surface.
Children aged 2-15 must be tested by an adult.
Children aged 2-12 must be swabbed with the Child Adapter in place.
Small children should be swabbed with the help of a second adult.
Keep out of reach of children.
DON’TS
Do not perform the test within 30 feet of another person using an Ellume COVID-19 Home Test.
Do not use test if foil packaging is damaged.
Do not perform tests in direct sunlight.
Do not touch the Tip of the Swab.
Do not close the App until your result is available.
Do not replace Processing Fluid with any other fluid. Avoid contact.
Do not add less than 5 drops of fluid to the Analyzer.
Do not use in children under 2 years of age.
No matter what your test result is, please consult a healthcare professional if your symptoms persist or become more severe.

GETTING STARTED

UNBOX COMPONENTS
Only open foil packaging when you are ready to do the test.
Use within 1 hour after opening.
DOWNLOAD & OPEN APP
Find the free Ellume COVID-19 Home Test App on the Google Play Store, the App Store or visit: www.ellumecovidtest.com
ANSWER A FEW QUESTIONS IN THE APP
This will select the right video and instructions for you and enable health authorities to monitor COVID-19 infection and test positivity rates.
WATCH INFO VIDEO
Get familiar with the test.
FOLLOW INSTRUCTIONS
The App has step-by-step instructions to guide you through the test after the video.

ellume COVID 19 Home Test - STARTED4

In the 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 the 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.

THE COLOR OF COMPONENTS MAY VARY

The color of the test components in the carton may vary from the image on the carton and within the Ellume COVID-19 Home Test App.

ellume COVID 19 Home Test - OMPONENTS

Need help?
Call us toll-free on 1-888-885-6121
No test component to be used inside the body except the Nasal Swab as directed.
Ellume Limited
57 Didsbury St, East Brisbane, Qld 4169, Australia