2

minutes

TTTT

C CCC

C CCC

TTTT

2

minutes

TTTT

C CCC

C CCC

TTTT

TTTT

CCCC

CCCC

TTTT

CLICK

STOP

TTTT

CCCC

CCCC

TTTT

CLICK

STOP

TTTT

CCCC

CCCC

TTTT

CLICK

STOP

INSTRUCTIONS FOR USE

KIT CONTENTS

A. PREPARING FOR THE TEST

2 Blow your nose. If you are 

testing someone else, have 

them blow their nose.

4 Gently insert the entire 

absorbent tip of the swab 

into the nostril no more 

than 1⁄2 to 3⁄4 inch. There is 

no need to go deeper. 

Slowly rotate the swab in a 

circular motion 5 times by 

firmly pressing against the 

inside walls of the nostril 

for 5 seconds.

Repeat in the other nostril 

using the same swab.

B. TAKING THE SAMPLE AND RUNNING THE TEST

STORAGE AND HANDLING

• Test kits must be stored at 35.6–86°F (2–30°C ) 

until use.

• Test kits must be stored out of reach of children. Discard 

any expired test kits in household waste.

• Do not reuse test components.

• Do not open the test kit until you are ready to test.

1. Read all the instructions before you start the test.

2. Check the test’s expiration date . Do not use an expired test. 

3. Wash your hands with soap and water for 20 seconds and dry 

them thoroughly, or use hand sanitizer.

4. Use a flat, level surface, (such as a table or countertop) for testing.

5. Use a timer during the test.

6. Make sure you have all the test components before you begin.

7. Bring test kit to room temperature (59-86°F /15-30°C)

8. Perform test at room temperature. Testing under conditions other than room 

temperature may lead to inaccurate results.

1 Peel open the notched foil pouch to unwrap 

the test device. Ensure that the test device is 

intact and that there are no green beads in 

the desiccant package 

(orange beads are 

expected). Do not use test if 

green beads are present. 

Place the test device on a 

flat surface with the top 

crown at the top.

5 While the test is still on the flat surface, insert the 

swab into the test at the top crown, pushing the swab 

all the way down into the center of the test cage. 

You will hear a “click”. 

6 Vigorously swing the test 

side to side for 4 seconds.

Do not attempt to shake 

up and down as this may 

cause incorrect results.

7 Set a timer for 2 

minutes. Allow the test 

to stand upright with 

the top crown up.

8 Turn the test upside down so that 

the top crown is at the bottom. Set a 

timer for 20 minutes.

Do not lay the test on 

its side.

Warning: Do not read the 

result before 20 minutes 

or after 30 minutes.

Make sure the top of the swab 

handle is pushed as far into the test 

as possible by firmly pressing the 

handle in with your thumb or an 

additional hand.

Do not proceed until 

you have confirmed 

that the swab handle 

is fully inserted.

Instructions for swabbing children: With 

children, you may not need to insert the swab

as far into the nostril. For very young children, 

you may need another person to hold the child’s 

head while swabbing.

Warning: Do not just spin the swab. Inaccurate 

test results may occur if the nasal swab 

specimen is not properly collected.

C. READING THE TEST RESULTS

WARNING: Do not read the result before 20 minutes or after 

30 minutes. Inaccurate test interpretations may occur.

Look at the result window and locate the letters C and T on the 

side of the window. A pink/purple line should always appear at 

the C position; this is a control line and signals that the test is 

working properly.

1 Sterile flocked nasal 

swab in a peel-pouch

1 Single-use, disposable test device 

in a notched foil pouch

Peel-pouch

Needed but not provided: clock or timer

Results 

window

Top 

crown

Test 

cage

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

3 Peel open the pouch to unwrap the swab. 

Make sure you hold the swab by the 

swab handle. Do not touch the swab tip.

< Negative result

If the Control (C) line is visible, but the Test (T) line is 

not visible, the test is negative.

To increase the chance that the negative result for 

COVID-19 is accurate, you should:

• Test again in 48 hours if you have symptoms on the 

first day of testing.

•Test 2 more times at least 48 hours apart if you do 

not have symptoms on the first day of testing.

A negative test result indicates that the virus that causes COVID-19 

was not detected in your sample. A negative result is presumptive, 

meaning it is not certain that you do not have COVID-19. You may 

still have COVID-19 and you may still be contagious. There is a 

higher chance of false negative results with antigen tests compared 

to laboratory-based tests such as PCR. If you test negative and 

continue to experience COVID-19-like symptoms, (e.g., fever, cough, 

and/or shortness of breath) you should seek follow up care with 

your health care provider.

< Positive result

If a Control (C) line and the Test (T) line are visible, 

the test is positive. Any faint visible pink/purple 

test (T) line with the control line (C) should be read 

as positive.

You do not need to perform repeat testing if you have 

a positive result at any time.

A positive test result means that the virus that causes COVID-19 was 

detected in your sample and it is very likely you have COVID-19 and 

are contagious. Please contact your doctor/primary care physician 

or your local health authority immediately and adhere to the local 

guidelines regarding self-isolation. There is a very small chance that 

this test can give a positive result that is incorrect (a false positive).

< Invalid result

If a control line (C) is not visible, even if the test line is 

visible, the result must be considered invalid. 

If the control (C) line is not visible, the test is invalid. 

Re-test with a new swab and new test device.

Continue pushing the swab all 

the way through until the swab 

handle is flush with the top 

of the device and you hear a 

second “click”.

20

minutes TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

20

minutes TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

CLICK

STOP

TTTT

CCCC

CCCC

TTTT

TTTT

CCCC

CCCC

TTTT

HOW TO USE THIS TEST

• Serial testing should be performed in all individuals with negative results; 

individuals with symptoms of COVID-19 and initial negative results should be 

tested again after 48 hours. Individuals without symptoms of COVID-19, and 

with initial negative results, should be tested again after 48 hours and, if the 2nd 

test is also negative, a 3rd time after an additional 48 hours. You may need to 

purchase additional tests to perform this serial (repeat) testing.

• If you test negative but continue to have symptoms of COVID-19, and both your 

first and second tests are negative, you may not have COVID-19, however you 

should follow-up with your healthcare provider.

• If your test is positive, then proteins from the virus that causes COVID-19 have 

been found in your sample and you likely have COVID-19.

For use with anterior nasal swab specimens.

For Emergency Use Authorization (EUA) only.

In vitro diagnostic use only.
The COVI-GoTM SARS-CoV-2 Ag Self-Test is a lateral flow immunoassay device intended for the qualitative detection of 

nucleocapsid protein antigen from the SARS-CoV-2 virus. 

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from 

individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years 

or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when 

tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other 

epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours 

between tests. 

The COVI-Go SARS-CoV-2 Ag Self-Test does not differentiate between SARS-CoV or SARSCoV-2. 

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior 

nasal (nares) samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but 

clinical correlation with patient history and other diagnostic information is necessary to determine infection status. 

Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be 

the definitive cause of disease. Individuals who test positive with the COVI-Go SARS-CoV-2 Ag Self-Test should selfisolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary. 

All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, 

may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis 

for treatment or patient management decisions, including infection control measures such as isolating from others and 

wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history, and 

the presence of clinical signs and symptoms consistent with COVID-19. 

Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of 

breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. 

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting 

and to receive appropriate medical care. All healthcare providers will report all test results they receive from individuals 

who use the authorized product to relevant public health authorities in accordance with local, state, and federal 

requirements, using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) 

Test Code Mapping for SARS-CoV-2 Tests provided by CDC. 

The COVI-Go SARS-CoV-2 Ag Self-Test is intended for non-prescription self-use and/or as applicable, for an adult lay 

user testing another aged 2 years or older in a non-laboratory setting. The COVI-Go SARS-CoV-2 Ag Self-Test is only for 

in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not 

been FDA cleared or approved.

• Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate 

test results.

• In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an 

Emergency Use Authorization. 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.

• Serial testing should be performed in individuals with negative results at least twice over three days (with 48 

hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between 

tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) 

testing. If you have had symptoms longer than 5 days you should consider testing at least three times over five 

days with at least 48 hours between tests.

• An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Children age 2 to 13 

years should be tested by an adult.

• Do not use on anyone under 2 years of age.

• Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.

• Do not use if any of the test kit contents or packaging is damaged.

• Test components are single-use. Do not re-use.

• Do not use kit past its expiration date.

• Do not touch the swab tip.

• Once opened, the test device should be used within 15 minutes.

• False results may occur if not tested at room temperature and in areas with high humidity.

• Do not read test results before 20 minutes or after 30 minutes. Results read before 20 minutes or after 30 minutes 

may lead to a false positive, false negative, or invalid result.

• If applicable: Keep testing kit and kit components away from children and pets before and after use. Avoid 

contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains 

harmful chemicals (see table below). If the solution contacts your skin, eyes, nose, or mouth, flush with large 

amounts of water.

• If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222. 

REF Number: 11619100 v13 Effective Date: 2023-2

Mologic Inc

83 Pineland Dr.

Gray Hall Suite 202

New Gloucester, ME 04260

WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION

FREQUENTLY ASKED QUESTIONS

• There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to 

the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in 

an individual with COVID-19 as compared to a molecular test, especially in samples with low viral load.

• The performance of this test was established based on the evaluation of a limited number of clinical specimens 

collected between August 2022 - November 2022. The clinical performance has not been established for all circulating 

variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical 

evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging 

strains of SARS- CoV-2 and their prevalence, which change over time.

• All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary. 

If you continue to have symptoms of COVID-19, and both your first and second tests are negative, you may not have 

COVID-19, however you should follow-up with a healthcare provider.

• If the test is positive, then proteins from the virus that causes COVID-19 have been found in the sample and you likely 

have COVID-19.

• This test is read visually and has not been validated for use by those with impaired vision or color-impaired vision.

• Incorrect test results may occur if a specimen is incorrectly collected or handled.

SERIAL TESTING AND LIMITATIONS

WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE TEST?

Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test result (see Warnings and Result Interpretation sections for more information).

Potential benefits include:

• The results, along with other information, can help you and your healthcare provider make informed 

recommendations about your care.

• The results of this test may help limit the potential spread of COVID-19 to your family and others in your 

community.

For more information on EUAs go here: https://www.fda.gov/emergency- preparedness-and-response/

mcm-legal-regulatory-and-policy-framework/emergency- use-authorization

WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?

There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests detect 

genetic material from the virus. Antigen tests, such as the COVI-GoTM SARS-CoV-2 Ag Self-Test detect 

proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give 

you a false negative result when you have COVID-19 than a molecular test would.

HOW ACCURATE IS THIS TEST?

Clinical studies have shown that antigen tests more accurately determine whether you are infected with the 

virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test 

accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more 

information on the performance of the test and how the performance may apply to you, please refer to the 

performance data in the Healthcare Provider Instructions for Use (IFU), available at www.covi-go.com.

WHAT IF I HAVE A POSITIVE TEST RESULT?

A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes 

COVID-19 were found in your sample. You should self- isolate from others and contact a healthcare provider 

for medical advice about your positive result.

WHAT IF I HAVE A NEGATIVE TEST RESULT?

A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in 

your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test 

again in 48 hours since antigen tests are not as sensitive as molecular tests. If you do not have symptoms 

and received a negative result, you should test at least two more times with 48 hours in between tests for a 

total of three tests. If you have a negative result, it does not rule out SARS- CoV-2 infection; you may still be 

infected and you may still infect others. It is important that you work with your healthcare provider to help 

you understand the next steps you should take.

WHAT DOES AN INVALID TEST RESULT MEAN?

An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new 

swab should be used to collect a new nasal specimen and you should test again with a new test.

IMPORTANT

• Do not use this test as the only guide to manage your illness. Consult your healthcare provider if your symptoms 

persist or become more severe.

• Individuals should provide all results obtained with this product to their healthcare provider.

Index of Symbols

Manufacturer Date of manufacture

Contains sufficient for <n> tests Catalogue number

In vitro diagnostic medical device Use-by date

Consult instructions for use Batch code

Store between 2-30°C / 36-86°F Do not reuse

Materials Provided

Components 1 Test

per Box

2 Tests

per Box

4 Tests

per Box

100 tests 

per box

COVI-GoTM SARSCoV-2 Antigen Test 

Device

1 2 4 100

COVI-GoTM Sterilized 

Swab 1 2 4 100

Quick Reference / 

Instructions for Use 1 1 1 1

INTENDED USE

Tel: +1-888-381-6870

Email: info@covi-go.com

www.covi-go.com

SERIAL TESTING TEST RESULT INTERPRETATION

Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results 

for COVID-19.

Results should be considered in the context of an individual’s recent exposures, history, and the presence of 

clinical signs and symptoms consistent with COVID-19.

Report your test result(s) at MakeMyTestCount.Org– this voluntary and anonymous reporting helps public 

health teams understand COVID-19 spread in your area and across the country and informs public health 

decisions.

Chemical Name / CAS Hazard Catergory Concentration

Sodium Azide

Cas-No: 26628-22-8

Acute Tox. 2 (Oral), H300

Acute Tox. 1 (Dermal), H310

0.05% in final solution

• For more information on EUAs please visit: https://www.fda.gov/emergency- preparedness-and-response/

mcm-legal-regulatory-and-policy-framework/emergency- use-authorization

• For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
21T0622D2B

COVID 2 test kit

MOLOGIC

8

/

[15.87]

41

2

/

[114.3]

2

3

4

/

[69.85]

41

2

/

[114.3]

22332

/

[69.06]

21116

/

[68.26]

7

3

8

/

[187.32]

21116

/

[68.26]

FOLD

FOLD

Glue Printside

Internal Glue Area

Internal Glue Area

Minor Panel

Minor Panel

SEAL END.018 SBS

4+1/2 x 2+3/4 x 7+3/8114.300 x 69.850 x 187.325

in.

mm

Fast and easy to use COVID-19 Self-Test for infection detection

Fast and easy to use COVID-19 SelfTest for infection detection

Fast and easy to use COVID-19 SelfTest for infection detection

detectionTest for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to FPO

Fast and easy to use 

COVID-19 Self-Test for 

infection detection

• 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.

• Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative 

result when you have COVID-19 than a lab-based molecular test. 

• For more information on expiration dating for COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests

SARS-CoV-2 Ag | Self-Test

SARS-CoV-2 Ag | Self-Test

COVID-19

ANTIGEN SELF TEST FOR 

INFECTION DETECTION

Fast and easy to use COVID-19 Self-Test for infection detection

Contents:

• 2 SARS-CoV-2 Ag Self-Test

• 2 sterile nasal sampling device

• 1 Instructions for Use

Items necessary to use the kit, but not provided

• Timer 

For symbol glossary, refer to Instructions for Use.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. 

For ages 13 and under, test must be administered by a caregiver.

Keep out of reach of children. The test contains small parts that may present a choking hazard.

The COVI-GoTM SARS-CoV-2 Ag Self-Test is a lateral flow immunoassay that uses antibodies to detect nucleocapsid protein from SARS-CoV-2 

in anterior nasal swabs from those with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three 

days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when 

tested at least three times over five days with at least 48 hours between tests.

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.

• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other 

viruses or pathogens.

© 2023 Mologic Inc: All rights reserved.

COVI-GoTM whenever used & COVI-Go is a trademark of Mologic 

Inc, New Gloucester, ME 04260

For more information, visit www.covi-go.com

Mologic Inc, 83 Pineland Dr. Gray Hall, Suite 202, New Gloucester, ME 04260

Store between 36-86oF (2-30oC) until use

HELP: Contact Mologic Technical Support at (888) 381-6870 or info@covi-go.com

IVD REF OTC

LOT Do not use if package 

is damaged

Consult instructions 

for use

Lot Number Single use only

Self test in vitro 

diagnostic device Date of manufacture In vitro diagnostic use Catalog Number

Suitable for age 2+ years

Suitable for 

age 2+ years

Part# 11618101, Version 3, 02/23

REF

LOT

SARS-CoV-2 Ag | Self-Test

Fast and easy to use COVID-19 

Self-Test for infection detection

Suitable for age 2+ years

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING

2 Tests

Fast and easy to use COVID-19 Self-Test 

for infection detection

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING

SARS-CoV-2 Ag | Self-Test

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use

In the USA, this product has not been FDA cleared or 

approved, but has been authorized by FDA under an EUA.
printed 10+7/32 x 10+3/8

20T0601A2

COVID 2PC KIT

MOLOGIC

[10.219]

259.556

[10.375]

263.525

[7.375]

187.325

[0.625]

15.875

[3.312]

84.137

[1.500]

38.100

[3.312]

84.137

[1.469]

37.306

[1.250]

31.750

[1.500]

38.100

FOLD

FOLD

Glue Printside

06/09/2021

.018 SBS

3+5/16 x 1+1/2 x 7+3/884.137 x 38.100 x 187.325

SARS-CoV-2 Ag | Self-Test

Fast and easy to use COVID-19 Self-Test 

for infection detection

Suitable for age 2+ years

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING 1 Test

Fast and easy to use COVID-19 Self-Test 

for infection detection

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING

SARS-CoV-2 Ag | Self-Test

COVID-19

ANTIGEN SELF TEST FOR 

INFECTION DETECTION

Fast and easy to use COVID-19 Self-Test for infection detection

Contents:

• 1 SARS-CoV-2 Ag Self-Test

• 1 sterile nasal sampling device

• 1 Instructions for Use

Items necessary to use the kit, but not provided

• Timer 

For symbol glossary, refer to Instructions for Use.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. 

For ages 13 and under, test must be administered by a caregiver.

Keep out of reach of children. The test contains small parts that may present a choking hazard.

The COVI-GoTM SARS-CoV-2 Ag Self-Test is a lateral flow immunoassay that uses antibodies to detect nucleocapsid protein from SARS-CoV-2 

in anterior nasal swabs from those with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three 

days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when 

tested at least three times over five days with at least 48 hours between tests.

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.

• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other 

viruses or pathogens.

© 2023 Mologic Inc: All rights reserved.

COVI-GoTM whenever used & COVI-Go is a trademark of Mologic 

Inc, New Gloucester, ME 04260

For more information, visit www.covi-go.com

Store between 36-86oF (2-30oC) until use

Suitable for age 2+ years

Suitable for age 2+ years

Mologic Inc, 83 Pineland Dr. Gray Hall, Suite 202, New Gloucester, ME 04260

HELP: Contact Mologic Technical Support at (888) 381-6870 or info@covi-go.com

REF

OTC

IVD

LOT Do not use if package 

is damaged

Consult instructions for use

Lot Number

Single use only

Self test in vitro diagnostic device

Date of manufacture In vitro diagnostic use Catalog Number

Part# 11618100, Version 3, 02/23

REF

LOT

FPO

detectionTest for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to 

Fast and easy to use COVID-19 SelfTest for infection detection

Fast and easy to use COVID-19 SelfTest for infection detection

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use

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.

• 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.

• Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative 

result when you have COVID-19 than a lab-based molecular test. 

• For more information on expiration dating for COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests
detection

Test for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to FPO

Fast and easy to use COVID-19 Self-Test for infection detection

Fast and easy to use COVID-19 SelfTest for infection detection

Fast and easy to use COVID-19 SelfTest for infection detection

Fast and easy to use COVID-19 

Self-Test for infection detection

SARS-CoV-2 Ag | Self-Test

SARS-CoV-2 Ag | Self-Test

COVID-19

ANTIGEN SELF TEST FOR 

INFECTION DETECTION

Fast and easy to use COVID-19 Self-Test for infection detection

Contents:

• 4 SARS-CoV-2 Ag Self-Test

• 4 sterile nasal sampling device

• 1 Instructions for Use

Items necessary to use the kit, but not provided

• Timer 

For symbol glossary, refer to Instructions for Use.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. For ages 13 and under, test must be administered by a caregiver. Keep out of reach of children. The test 

contains small parts that may present a choking hazard.

The COVI-GoTM SARS-CoV-2 Ag Self-Test is a lateral flow immunoassay that uses antibodies to detect nucleocapsid protein from SARS-CoV-2 in anterior nasal swabs from those with symptoms of COVID-19 within the first 5 days of symptom onset when tested 

at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.

• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

© 2023 Mologic Inc: All rights reserved.

COVI-GoTM whenever used & COVI-Go is a trademark of Mologic 

Inc, New Gloucester, ME 04260

For more information, visit www.covi-go.com

Mologic Inc, 83 Pineland Dr. Gray Hall, Suite 202, New Gloucester, ME 04260

Store between 36-86oF (2-30oC) until use

HELP: Contact Mologic Technical Support at (888) 381-6870 or info@covi-go.com

REF OTC

LOT IVD Do not use if package 

is damaged

Consult instructions 

for use

Lot Number Single use only

Self test in vitro 

diagnostic device

Date of manufacture In vitro diagnostic use

Catalog Number

Suitable for age 2+ years

Suitable for 

age 2+ years

Part# 11618120, Version 3, 02/23

REF

LOT

SARS-CoV-2 Ag | Self-Test

Fast and easy to use COVID-19 Self-Test 

for infection detection

Suitable for age 2+ years

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING 4 Tests

Fast and easy to use COVID-19 Self-Test for infection detection

SARS-CoV-2 Ag | Self-Test

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use

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.

• 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.

• Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test. 

• For more information on expiration dating for COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests
detection

Test for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to 

detectionTest for infection use COVID-19 SelfFast and easy to FPO

Fast and easy to use COVID-19 Self-Test for infection detection

Fast and easy to use COVID-19 SelfTest for infection detection

Fast and easy to use COVID-19 SelfTest for infection detection

Fast and easy to use COVID-19 

Self-Test for infection detection

SARS-CoV-2 Ag | Self-Test

SARS-CoV-2 Ag | Self-Test

COVID-19

ANTIGEN SELF TEST FOR 

INFECTION DETECTION

Fast and easy to use COVID-19 Self-Test for infection detection

Contents:

• 100 SARS-CoV-2 Ag Self-Test

• 100 sterile nasal sampling device

• 1 Instructions for Use

Items necessary to use the kit, but not provided

• Timer 

For symbol glossary, refer to Instructions for Use.

A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. For ages 13 and under, test must be administered by a caregiver. Keep out of reach of children. The test 

contains small parts that may present a choking hazard.

The COVI-GoTM SARS-CoV-2 Ag Self-Test is a lateral flow immunoassay that uses antibodies to detect nucleocapsid protein from SARS-CoV-2 in anterior nasal swabs from those with symptoms of COVID-19 within the first 5 days of symptom onset when tested 

at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.

• This test does NOT determine if you had COVID-19 in the past or if you have immunity.

• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

© 2023 Mologic Inc: All rights reserved.

COVI-GoTM whenever used & COVI-Go is a trademark of Mologic 

Inc, New Gloucester, ME 04260

For more information, visit www.covi-go.com

Mologic Inc, 83 Pineland Dr. Gray Hall, Suite 202, New Gloucester, ME 04260

Store between 36-86oF (2-30oC) until use

HELP: Contact Mologic Technical Support at (888) 381-6870 or info@covi-go.com

REF OTC

LOT IVD Do not use if package 

is damaged

Consult instructions 

for use

Lot Number Single use only

Self test in vitro 

diagnostic device

Date of manufacture In vitro diagnostic use

Catalog Number

Suitable for age 2+ years

Suitable for 

age 2+ years

Part# 11618105, Version 3, 02/23

REF

LOT

SARS-CoV-2 Ag | Self-Test

Fast and easy to use COVID-19 Self-Test 

for infection detection

Suitable for age 2+ years

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING 100 Tests

Fast and easy to use COVID-19 Self-Test for infection detection

SARS-CoV-2 Ag | Self-Test

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING

FAST RESULTS 

IN 20 MINUTES

EASY 

TESTING

• 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.

• Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test. 

• For more information on expiration dating for COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.