SARS-CoV-2 Antigen 

For Self-testing

For use under Emergency Use Authorization (EUA) Only

For In vitro diagnostic use

COVID-19 Ag Home Test

• Wash hands with soap or hand sanitizer and dry thoroughly.

• Using the enclosed tube holder is optional. When testing

with the holder, please beware of buffer spillage.

• Test Device should be used within 60 minutes after opening

the pouch.

1. Check all components before testing.

1. Peel off the foil cover from the pre-filled tube.

2. Insert the tube upright into the tray hole.

1. After collecting the sample with the swab, insert the swab

into the pre-filled tube.

2. Using both hands, carefully remove the tube and swab

together.

2. Open the pouch and lay the test device on a flat surface.

3. Blow your nose thoroughly and clear the nasal passage.

3. Squeeze the sides of the tube and twirl the swab in the

 liquid at least 10 times. (A false negative result may occur

 if the swab is not twirled at least 10 times).

4. While slowly removing the swab, continue squeezing the

 tube to make sure all the liquid is extracted from the swab.

 Discard the swab.

5. Attach the filter cap by firmly pushing it vertically onto

 the tube and place the tube back into the tray.

6. Invert the tube and hold the sample vertically above the

 sample well. Carefully squeeze 4 drops of the solution

 into the sample well.

7. Wait 15 minutes and read the result. Do not read the result

 after 20 minutes. Inaccurate results may occur if the test

 result is read before 15 minutes or after 20 minutes.

Carefully read the instructions before performing the test. Failure 

to follow the instructions may produce inaccurate test results.

Precautions Before the Test

STORAGE & EXPIRATION

DISPOSAL

01

03 Sample Collection 04 Test Procedure

02 Preparation

4. Remove the swab from the packaging

 

 

 

 

DO NOT EAT.

NE PAS MANORE 먹지마세요.

Valid Invalid

후레쉬메이커

☎ TEL. (031)798-6388

SILICA GEL

1

COVID-19 Ag

C T

5 X 5 X

Wait until 15 minutes

15 - 20 MIN

Read the result at 15 - 20 minutes

The type of the tray differs depending on the product 1. GenBody COVID-19 Ag kit should be stored between 35.6 to 86 °F catalog. (2 to 30 °C). Ensure all test components are at room temperature

before use.

2. Check the expiration date listed on test device pouch.

3. For the most current expiration dates of this test, please refer to:

http://www.fda.gov/covid-tests.

Place all used kit components and the swab samples back in the 

pouch and dispose the pouch in household waste.

OC VID-19

gA

S

Cat# U-02 Cat# U-01, 05, 25

Inadequate sample extraction can result in incorrect

results.

False negative results can occur if the specimen is not

properly mixed or too vigorously mixed.

Avoid exposure of your skin, eyes, nose or mouth to

the solution in the tube.

For test accuracy, make sure to collect sample from

both nostrils.

A false negative result may occur if the nasal swab

specimen is not properly collected.

Wear a face mask if swabbing others.

DO NOT insert the swab any deeper if you feel

resistance or pain.

Do not touch the result window or the sample

well of the test device.

Adding other than recommended number of drops

may result in incorrect results.

Do not touch the result window or the sample well

of the test device.

Do not add sample to the rectangular result window.

False positive or false negative results can occur if test

device is read before 15 minutes or after 20 minutes.

OC VID-19

gA

OC VID-19

gA

OC VID-19

gA

COVID-19 Negative(-)

05 Test Interpretation

Invalid

If the control (C) line is not visible,

the test is invalid. Re-test with a

new device and new swab. 

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

the test is positive. Any faint visible reddish 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).

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

or 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.

Serial (Repeat) testing

Repeat testing is needed to improve test accuracy. Please follow 

the table below when interpreting test results for COVID-19.

Status on First

Day of Testing

First Result

Day 1

Second Result

Day 3

Third Result

Day 5 Interpretation

With symptoms

Without

symptoms

Positive

Positive

Positive

N/A N/A

N/A

N/A

N/A

N/A

N/A

Positive

Positive

Positive for COVID-19

Positive for COVID-19

Negative for COVID-19

Negative for COVID-19

Positive for COVID-19

Positive for COVID-19

Positive for COVID-19

Negative

Negative

Negative

Negative

Negative

Negative

Negative Negative

Negative

Invalid

Negative

Positive

Report your test result(s) at https://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.

Date of last Revision

2023.02 (Rev.0)

Donot touchswabheador laytheswabonanysurface.

5. Collectthenasal swabsample

Results shouldbe consideredinthe contextof anindividual’s

recentexposures,history,andthepresenceofclinical signs

and symptoms consistent withCOVID-19.

COVID-19 Positive(+)

1) Self-collection

A nasal swab sample can be self-collected by an individual

aged 14 years and older. For self-collection, insert the swab

about a half inch deep into the nostril and slowly rub along

the inside wall five times for 15 seconds with medium

pressure. Repeat the process in the other nostril.

 2) Child specimen collection

Children aged 2 to 13 years should be tested by an

adult. Gently insert the entire tip of the swab head into

the child's nostril (1⁄2 to 3⁄4 of an inch). With children, the

maximum depth of insertion may be less than 3⁄4 of an

inch and you may need a second person to hold the

child's head while swabbing. Slowly rub along the inside

wall five times for 15 seconds and repeat the process in

the other nostril.
GenBody COVID-19 Ag Home Test

for FDA Emergency Use Authorization (EUA) Only 

Frequently Asked Questions

Warnings, Precautions, and Safety Information

 

 

WHAT IS THE DIFFERENCE BETWEEN A COVID-19 ANTIGEN TEST AND A 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 GenBody COVID-19 Ag Home 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.

WHAT IS SERIAL TESTING?

COVID-19 serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every 

other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. For the 

serial testing procedure, please refer to the ‘How to Use This Test’ section. You may need to purchase additional tests to 

perform this serial (repeat) testing. 

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 https://www.genbodyhometest.com.

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

Potential risks include:

• Possible discomfort or other complications that can happen 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 please visit: https://www.fda.gov/emergency-preparedness-andresponse/mcm-legalregulatory-and-policy-framework/emergency-use-authorization

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.

 

 

 

 

 

Chemical Name

Sodium azide 0.09%

GHS Code for each Ingredient Concentration

H302+H312, Harmful if swallowed or in contact with skin

Limitations

1. 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

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

2. This device is only used for testing direct human anterior nasal swab specimens. Viraltransport media (VTM) should

not be used with this test.

4. The performance ofthe GenBody COVID-19 Ag Home Test was evaluated using the procedures provided in these

Instructions for Use (IFU) only. Modifications to these procedures may alter the performance ofthe test.

12. The performance ofthis test was established based on the evaluation of a limited number of clinical specimens

collected between November 2021 - September 2022 .The clinical performance has not been established for all

circulatingvariantsbutisanticipatedtobereflectiveoftheprevalent variants incirculationatthetimeandlocationof

the clinical evaluation .Performance atthe time oftesting may vary depending onthe variants circulating ,including

newlyemergingstrainsofSARS-CoV-2andtheirprevalence,whichchangeover time.

Use-by date

Manufacturer

Batch code In vitro diagnostic device Catalogue number Consult instructions

for use

Contains sufficient for

<n> tests Temperature limit Do not re-use Test Device

INTERNATIONAL SYMBOL USAGE

You may see one or more of these symbols on the labeling/packaging of this product.

For Technical Help, please contact:

Technical Support (US)

Tel: (888) 552-5204

Email: ts@genbodyamerica.com

Web: www.genbodyhometest.com

Manufacturer

GenBody Inc.

3-18, Eopseong 2-gil, Seobuk-gu, Cheonan-si, 

Chungcheongnam-do, 31077, Republic of Korea

Tel: +82-41-523-8993 (International)

Email: contact@genbody.co.kr

Website: http://www.genbody.co.kr

US Distributor / US Agent

Kwell Laboratories, LLC

3420 De Forest Circle Jurupa Valley, CA 91752 USA

Tel: (949) 561-0664

Email: inquire@kwellabs.com

Website: www.kwellabs.com

COVAGHT2-U-01, COVAGHT2-U-02, COVAGHT2-U-05, COVAGHT2-U-25.

Doc. No.: I-164-EN-R0-202302-US

 

INTENDED USE

The GenBody COVID-19 Ag Home Test is a lateral flow chromatographic immunoassay 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 GenBody COVID-19 Ag Home Test does not differentiate between SARS-CoV and SARS-CoV-2.

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

anterior nasal(nares) swab samples during the acute phase ofinfection. Positive results indicate the presence of

viral antigens, but clinical correlation with past medical 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 GenBody COVID-19 Ag Home Test should self-isolate and seek follow-up care with their physician or

healthcare provider as additional testing may be necessary.

All negative results are presumptive and con firmation 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-like symptoms of fever, cough and/or shortness

of breath may still have SARS-CoV-2 infection and should seek follow up care from 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 inaccordance with

local, state ,and federal requirements using appropriate LOINC and SNOMED codes ,asdefined by the Laboratory

InVitroDiagnostics (LIVD)TestCodeMappingforSARS-CoV-2TestsprovidedbyCDC.

The GenBody COVID-19 Ag Home Test is intended for non-prescription self-use and/or, as applicable, an adult lay

user testing another person aged 2 years or older in a non-laboratory setting.

The GenBody COVID-19 Ag Home Test is only for use under the Food and Drug Administration’s Emergency Use

Authorization. This product has not been FDA cleared or approved.

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 additionaltests 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 testis positive,then proteins from the virus that causes COVID-19 have been found in your sample and you

likely have COVID-19.

3. Incorrecttest results may occur if a specimen is incorrectly collected or handled.

5. This test detects both viable (live) and nonviable SARS-CoV-2. Test performance depends on the amount of virus

(antigens)in the sample and may or may not correlate with viral culture results performed on the same sample.

6. Ifthe patient continues to have symptoms of COVID-19, and both the patient’s first and second tests are negative,

the patient may not have COVID-19, however additional follow-up may be needed.

7. Failure to follow the Test Procedure may adversely affecttest performance and/or invalidate the test result.

8. Positive test results do not rule out co-infections with other pathogens.

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

be necessary.

10. This testis read visually and has not been validated for use by those with impaired vision or color-impaired vision.

11. Ifthe testis positive,then proteins from the virus that causes COVID-19 have been found in the sample and you

likely have COVID-19.

1. Read all instructions carefully before performing the test. Failure to follow the instruction may resultin

inaccurate test results.

2. IntheUSA,thisproduct hasnotbeenFDAcleared orapproved,buthasbeenauthorized by FDAunder anEmergency

UseAuthorization.Thisproduct hasbeenauthorized only for thedetection ofproteins fromSARS-CoV-2,notforany

other viruses orpathogens.The emergency useofthisproductisonly authorized for theduration ofthedeclaration

thatcircumstancesexistjustifyingtheauthorizationofemergencyuseofinvitrodiagnostics fordetectionand/or

diagnosisofCOVID-19underSection564(b)(1)ofthe Federal Food,Drug, andCosmeticAct, 21 U.S.C.§360bbb-3(b)

(1), unless the declaration is terminated or authorization is revoked sooner.

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

hoursbetweentests)for symptomatic individuals andthree timesoverfivedays (withat least48hoursbetween

tests)for asymptomatic individuals .You may need topurchase additional tests toperform this serial (repeat )

testing.

4. If you have had symptoms longer than 5 days, you should consider testing atleastthree times over five days with

at least 48 hours between tests.

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

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

13 years of age should be tested by an adult.

7. Do not use kit pastits expiration date.

8. Do not use if any ofthe test kit contents or packaging is damaged.

9. Test components are single use only and should be discarded after use. Do not re-use.

10. Once opened,the test device should be used within 60 minutes.

11. Do not read test results before 15 minutes or after 20 minutes. Results read before 15 minutes or after 20

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

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

13. Do not use nasal sprays for at least 30 minutes before collecting a nasal sample.

14. Do nottouch the swab tip at any time during the test process.

15. Do not use the test device ifthe desiccant included in the foil pouch has changed from yellow to green.

16. Swabs included in the kit are approved for use with the GenBody COVID-19 Ag Home Test. Do not use other swabs.

17. For additional information on safety, handling, please email or call Technical Support at ts@genbodyamerica.

com or (888)-552-5204

18. Keeptesting kit andkit components away fromchildren andpetsbefore andafteruse.Avoidcontact withyour

skin or eyes. Do not ingest any kit components . The reagent solution contains harmful chemicals (see table

below). If the solution contacts your skin or eyes, flush with large amounts of water.

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

19. For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-andresponse/mcm- legal

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

20. For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
1 test kit box

122 x 83 x 30 mm

COVAGHT2-U-01

4 Drops

Questions? 

Go to 

www.genbodyhometest.com 

or call (888) 552-5204

Email: 

ts@genbodyamerica.com 

The GenBody COVID-19 Ag Home Test is lateral flow immunoassay that uses antibodies to

detect nucleocapsid protein from SARS-CoV-2. The GenBody COVID-19 Ag Home Test is a

non-prescription home test intended forthe qualitative detection of SARS-CoV-2 in anterior

nasal swab samples self collected from individuals aged 14 years or older or adult-collected

from individuals aged 2 years or older. This testis authorized forindividuals within the first 5

days symptom onset when tested at least twice over three days with at least 48 hours

between tests, and forindividuals without symptoms when tested atleastthree times over fi

ve dayswith atleast 48 hours between tests.

3-18, Eopseong 2-gil, Seobuk-gu

Cheonan-si, Chungcheongnam-do

31077, Republic of Korea

Tel: +82-41-523-8993 

3420 De Forest Circle

Jurupa Valley, CA 91752 USA

Tel: (949) 561-1664 

US Distributor

Kwell Laboratories

Blank for UDI

Barcode

1

4

2

5

3

6

Store between 35.6-86°F (2~30°C) until use

www.genbodyhometest.com

35.6°F

86°F

OTC 1

Contents

COVID-19

Ag

C T S

COVID-19

Home Test

Antigen

Results in 15 min

Comfortable 

nasal swab

1 Test

Ag

1 Test

COVID-19

Home Test

Antigen

COVID-19

Home Test

Antigen

B-164(01)-EN-202302-US • Determining a negative result requires multiple tests.

a

serial (repeat) testing. This test is more likely to give you

you may need to purchase additional tests to perform

 false negative result when you have COVID-19 than a

lab-based molecular test.

• F

• For in vitro diagnostic use

• For Emergency Use Authorization (EUA) only

or the most current expiration dates of this test, please

refer to: https://www.fda.gov/covid-tests.

U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21

declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for

any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the

Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for

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

• 1 Test Device

• 1 Extraction Tube

• 1 Filter Tip

• 1 Nasal Swab

• 1 Instruction Sheet

• Needed but not provided:

Timer, Tissue 
2 test kit box

156.4 x 93 x 43.8 mm

4 Drops

Rev.0

Store between 35.6-86°F (2~30°C) until use

www.genbodyhometest.com

COVID-19

Home Test

Antigen

COVID-19

Home Test

Antigen

35.6°F

86°F

OTC

Contents

COVID-19

Ag

C T S

COVID-19

Home Test

Antigen

Results in 15 min

Comfortable 

nasal swab

2 Tests 2 Tests 3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, Chungcheongnam- do 31077, Republic of Korea Tel: +82-41-523-8993 US Distributor Kwell Laboratories 3420De ForestCircle JurupaValley,CA91752 USATel:(949) 561-1664

B-164(02)-EN-202302-US

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.

The GenBody COVID-19 Ag Home Test is a non-prescription home testintended for the qualitative detection of SARS-CoV-2 in anterior nasalswab samples self collected from individuals aged 14 years or older oradult -collected from individuals aged 2 years or older . This test isauthorized for individuals

within the first 5 days symptom onset

when

tested at least twice over three days with at least 48 hours between tests,and forindividuals

without symptoms when tested at least three times

over five days

withat least 48 hours between tests.

orGo to www.genbodyhometest.com

Questions? 

call (888) 552-5204

Email:ts

@genbodyamerica.com

COVAGHT2-U-02

•

you may need to purchase a

Determining a negative result requires multiple tests.

dditional 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 Emergency Use Authorization (EUA) only

• For in vitro diagnostic use

• For the most current expiration dates of this test, please

refer to: https://www.fda.gov/covid-tests.

• 2 Test Device

• 2 Extraction Tube

• 2 Filter Tip

• 2 Nasal Swab

• 2 Instruction Sheet

• Needed but not provided:

Timer, Tissue

Blank for UDI

barcode

The GenBody COVID-19 Ag Home Test is lateral flow im

munoassay that

uses antibodies to detect nucleocapsid protein from SARS-CoV-2.
5 test kit box

170 x 124 x 61 mm

4 Drops

1 2 3 4 5 6

Store between 35.6-86°F (2~30°C) until use

www.genbodyhometest.com

Rev.0

Blank for UDI

barcode

Questions? 

Go to 

www.genbodyhometest.com

or call (888) 552-5204

Email: ts@genbodyamerica.com

3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, 

Chungcheongnam-do 31077, Republic of Korea Tel: +82-41-523-8993 

US Distributor Kwell Laboratories

3420 De Forest Circle

Jurupa Valley, CA 91752 USA Tel: (949) 561-1664 

• 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 tests.

• For Emergency Use Authorization (EUA) only

• For in vitro diagnostic use

• For the most current expiration dates of this test, please refer to: http://www.fda.gov/covid-tests.

35.6°F

86°F

OTC 5

COVID-19

Ag

C T S

COVID-19

Home Test

Antigen

Comfortable nasal swabResults in 15 min

Tests

5

Contents

B-164(05)-EN-202302-US

• 5 Test Device• 5 Extraction Tube• 5 Filter Tip• 5 Nasal Swab• 5 Instruction Sheet• Needed but not provided:

Timer, Tissue

The GenBody COVID-19 Ag Home Test is a non-prescription home test intended for the qualitative detection ofSARS-CoV-2 in anterior nasal

swab samples self collected from individuals aged 14 years or older or adult- collected from individuals aged 2 years or older. This test

is authorized for individuals within the first 5 days symptom onset when tested at least twice over three days with at least 48 hours

between tests, and for individuals without symptoms when tested at least three times over five days with at least 48 hours betweentests.

COVAGHT2-U-05

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.

The GenBody COVID-19 Ag Home Testis lateral flow immunoassay that uses antibodies to detect nucleocapsid protein from SARS-CoV-2.
25 test kit box

300 x 125 x 90 mm

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.

4 Drops

1 2 3

4 5 6

Results in 15 ~

20 minutes

Read the

instructions 

carefully before

testing

DO NOT Use after

Expiration date

Store at 35.6-86°F 

(2~30°C)

Detection of SARS-CoV-2 Antigen

US Distributor 

Kwell Laboratories 

3420 De Forest Circle, Jurupa Valley, CA 91752, USA

Tel: (949) 561-0664

3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, Chungcheongnam-do, 31077, Republic of Korea 

Tel: +82-41-523-8993, Fax: +82-41-523-8991, Email: contact@genbody.co.kr, Website: http://genbody.co.kr 

COVID-19 Ag Home Test

Store between 35.6-86°F (2~30°C) until use

www.genbodyhometest.com

35.6°F

86°F

OTC

COVAGHT2-U-25

Blank for UDI

barcode

Questions? 

Go to

www.genbodyhometest.

com or call (888) 552-5204

Email: ts@genbodyamerica.com

Rev.0

35.6°F

86°F

OTC

US Distributor 

Kwell Laboratories 

3420 De Forest Circle, Jurupa Valley, CA 91752, USA

Tel: (949) 561-0664

COVID-19 Ag Home Test

Cheonan-si, Chungcheongnam-do, 3-18, Eopseong 2-gil, Seobuk-gu 

31077, Republic of Korea 

Tel: +82-41-523-8993, Fax: +82-41-523-8991, 

Email: contact@genbody.co.kr, Website: http://genbody.co.kr 

Detection of SARS-CoV-2 Antigen

COVID-19

Ag

C T S

Results in 15 min

Comfortable 

nasal swab

Store between 35.6-86°F (2~30°C) until use

www.genbodyhometest.com

Contents

B-164(25)-EN-202302-US

For the most current expiration dates of this test, please refer to:

http://www.fda.gov/covid-tests.

25 Test Device •

25 Extraction Tube •

25 Filter Tip •

25 Nasal Swab •

5 Instruction Sheet •

Needed but not provided: •

Timer, Tissue

• 25 Test Device

• 25 Extraction Tube

• 25 Filter Tip

• 25 Nasal Swab

• 5 Instruction Sheet

• Needed but not provided:

Timer, Tissue 

TheGenBodyCOVID-19AgHomeTestisanon-prescriptionhometestintendedfor thequalitative

detection of SARS-CoV-2 in anterior nasal swab samples self collected from individuals aged

14yearsorolderoradult-collected fromindividuals aged2yearsorolder.This testisauthorized

for individuals within thefirst 5days symptom onset when tested atleasttwice over three days

withatleast 48hoursbetween tests ,andfor individuals without symptoms whentestedatleast

threetimesoverfivedayswithatleast48hoursbetweentests.

• 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 tests.

• For Emergency Use Authorization (EUA) only

• For in vitro diagnostic use

• For the most current expiration dates of this test, please refer to: 

http://www.fda.gov/covid-tests.

The GenBody COVID-19 Ag Home Test is lateral flow immunoassay that uses antibodies to

detect nucleocapsid protein from SARS-CoV-2.