1
UNBOX COMPONENTS
Only open foil packaging when
you are ready to do the test.
Use within 1 hour after opening.
2
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
3
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.
4
WATCH INFO VIDEO
Get familiar with the test.
5
FOLLOW INSTRUCTIONS
The App has step-by-step instructions
to guide you through the test after
the video.
Refer to the Product Information Leaet
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.
Follow the in-app instructions when
performing the test.
Keep your phone within 3 inches
of the Analyzer until the test result
is available.
KeeptheAnalyzeronaatsurface.
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.
GETTING STARTED
Please turn over
No matter what your test result is, please consult a healthcare
professional if your symptoms persist or become more severe.
DO’S DON’TS
QUICK START GUIDE
Need help? Call us toll free on on 1-888-885-6121
No test component to be used
inside the body except the Nasal
Swab as directed.
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.
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 test 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
otheruid.Avoidcontact.
Donotaddlessthan5dropsofuid
to the Analyzer.
Do not use in children under 2 years of age.
D1013515A
Ellume Limited
57 Didsbury St, East Brisbane, Qld 4169, Australia
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