QUICK REFERENCE INSTRUCTIONS At-Home OTC 

For technical support, please email support@cordx.com 

COVID-19 Ag Test

FOR use under emergency use authorization (EUA) only. 

FOR in vitro diagnostic use only.

Children of 2-13 years old should be tested by an adult.

Store the kit at 36~86°F/2~30°C. Bring the kit to room 

temperature (59~86°F/15~30°C) before the test. 

Read the instructions carefully before use. 

Scan for

instructions and timer 

A false result may occur if all the test steps are 

not followed as indicated below. If you skipped 

or incorrectly performed one or more steps, 

repeat the test with a new sample and cassette. 

TEST COMPONENTS 

Pre-made hole for tube 

Tube holder 

Result 

window 

Sample

well 

Test cassette 

QRI Swab 

Tube with 

sample

processing

solution 

Timer 

(not

included) 

TEST PREPARATION 

A Wash hands before testing. 

B Check Expiration Date on the package.

Do not use expired test kit! 

For most current shelf-life 

information of this test lot, please

refer to the following link:

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

C Remove the test cassette from the pouch and

place it on a clean, flat surface. 

D Insert the tube in the pre-made 

hole on the back of the kit box. 

E Remove the foil from the top of 

the tube. 

STEP 1: COLLECT SAMPLE 

Pull Pull

Do Not 

Touch Tip 

A Remove the swab from the pouch. 

Note: Be careful not to touch the swab 

tip (soft end) with hand. 

Right nostril 

5X 

Left nostril 

5X 

B Carefully insert the swab tip into one nostril about 1/2 to 3/4 inch.

Firmly and slowly rotate the swab 5 times, brushing against the inside 

walls of the nostril to ensure both mucus and cells are collected. 

• Do not push the swab further if you meet resistance.

• For young children do not insert more than 1/2 inch. 

C Using the same swab, repeat this process for the other nostril to

ensure an adequate sample is collected from both nostrils.

Note: Failure to swab properly may cause incorrect results. 

STEP 2: PROCESS SAMPLE 

10X 

A Insert the swab in tube to the bottom. 

B Rotate the swab at least 10 times 

while pressing the swab head against

the bottom and side of the tube. 

squeeze 

C Remove the swab while squeezing the sides of the tube to

express as much liquid as possible from the swab. 

D Attach the dropper tip firmly onto the tube. 

STEP 3: ADD SAMPLE 

3 drops 

Gently squeeze the tube and dispense 3 drops of solution

into the sample well. 

Note: A false negative or invalid result may occur if less 

than 3 drops of fluid are added to the Sample Well. 

STEP 4: READ RESULT 

Wait 10 minutes 

Read the result at 10 minutes 

Do not read the result after 30 minutes 

Note: The result is valid when read at 10-30minutes. If a 

POSITIVE result is obtained within 10 minutes, it should 

also be considered valid. 

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. 

TEST INTERPRETATION

POSITIVE NEGATIVE INVALID 

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. 

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 

Positive N/A N/A Positive for COVID-19 

Negative Positive N/A Positive for COVID-19 

Negative Negative N/A Negative for COVID-19 

Without Symptoms 

Positive N/A N/A Positive for COVID-19

Negative Positive N/A Positive for COVID-19 

Negative Negative Positive Positive for COVID-19 

Negative Negative Negative Negative for COVID-19 

COVID-19 Positive (+)

If the Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible colored 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). 

COVID-19 Negative (-)

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. 

Invalid 

If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device. 

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. 

KIT STORAGE AND STABILITY 

Storage: store at 36~86°F/2~30°C in a place out of direct sunlight and out of reach of children.

Reagents and devices must be used at room temperature (59~86°F/15~30°C). The unsealed cassette is valid for 1 hour. It is 

recommended to use the testing kit immediately after opening. The expiration date (Use-by date) is printed on the package. 

* Please refer to the instructions for use for more information PI2022001 Rev.05, 11/17/2022 
 

 

 

 

 

 

 

 

 

 

 

 

 

INTENDED USE 

The CorDx COVID-19 Ag 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 two years or older. This test is authorized 

for individuals with symptoms of COVID-19 within the first 7 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 CorDx COVID-19 Ag 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 specimens during the acute phase of infection. 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. The agent detected may not be the definite cause of disease. Individuals who test 

positive with the CorDx COVID-19 Ag 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 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 CorDx COVID-19 Ag Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another person 2 

years of age or older in a non-laboratory setting. The CorDx COVID-19 Ag Test is only for use under the Food and Drug 

Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved. 

WARNINGS, PRECAUTIONS AND SAFETY INFORMATION 

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

• If you skipped or incorrectly performed one or more steps, repeat the test with a new sample and cassette. 

• 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 7 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 aged 14 years and older. Children aged 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 card should be used within 60 minutes. • Do not read test results before 10 minutes or after 30 minutes. Results read before 10 minutes or after 30 minutes 

may lead to a false positive, false negative, or invalid result. • If uncertain how to proceed, contact Technical Assistance at support@cordx.com. • This product is only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. • When collecting an anterior nasal swab sample, only use the swab provided in the kit. • Inadequate or inappropriate specimen collection, may yield false negative test results. • Testing should be performed in an area with good lighting. • Dispose of all materials in household waste. • Wash hands thoroughly or use hand sanitizer before and after the test. • For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization • For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID-19 • Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your 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. 

Chemical Harms (GHS Code) for each ingredient Concentrations 

Triton X-100 Harmful if swallowed (H302) Causes skin irritation (H315) Causes serious eye damage (H318) 0.50% 

ProClin 300 Harmful if swallowed (H302) Harmful if inhaled (H332) Causes severe skin burns and eye damage (H314) May cause an allergic

skin reaction (H317) 0.05% 

LIMITATIONS 

• 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 

March 2022 and May 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 SARSCoV-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. 

FREQUENTLY ASKED QUESTIONS 

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

Potential risks include: a) Possible discomfort during sample collection. b)Possible incorrect test result (see Warnings and Result 

Interpretation sections for more information). 

Potential benefits include: a) The results, along with other information, can help you and your healthcare provider make informed 

recommendations about your care. b) 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-regulatoryand-policy-framework/emergency-use-authorization 

2) 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 CorDx COVID-19 Ag 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. 

3) 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) 

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/invitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 

4) 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. 

5) 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. 

6) 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. 

INDEX OF SYMBOLS 

Do not re-use Use-by date (Expiration date) Catalogue number 

Batch code Consult instructions 

for use Keep dry 

36°F

86°F Store at 36~86°F/2~30°C Manufacturer Keep away from sunlight 

Caution Do not use if package is damaged and

consult instructions for use 

CorDx, Inc. 

9540 Waples St. Unit C, 

San Diego, CA 92121 

Manufacturing sites: 

CorDx, Inc. 

8940 Kenamar Dr, San Diego, CA 92121, 

3719 North Peachtree Rd, Suite 200, Chamblee, GA 30341 

Core Technology Co., Ltd. 

No.30, Area 9, Douda Avenue, Fangshan District, Beijing 102433, China 
Fast Results

1 Test

At Home OTC

COVID-19 Ag Test Refer to the outer packaging of the product for the (Batch code) and (Expiration date) http://www.fda.gov/covid-tests For most current shelf-life information of this test lot, please refer to the following link: Use within 1 hour of opening

For Use under FDA Emergency 

Use Authorization (EUA) only
2 Tests

Manufacturing sites: CorDx, Inc.8940 Kenamar Dr, San Diego, CA 92121, 3719 North Peachtree Rd, Suite 200, Chamblee, GA 30341Core Technology Co., Ltd.No.30, Area 9, Douda Avenue, Fangshan District, Beijing 102433, China

CorDx, Inc. 9540 Waples St Unit C, San Diego, CA 92121Web: CorDx.comEmail: info@CorDx.com

TEST COMPONENTS: 2 Test cassettes 2 Swabs 2 Tubes with sample processing solution2 Tube holders (back of box) 1 Instructions for use

The CorDx COVID-19 Ag Test is intended for the qualitative 

detection of SARS-COV-2 nucleocapsid protein antigen in 

anterior nasal (nares) swab samples.

COVID-19 Ag Test 

Read the QRI and instructions fully and carefully 

before performing the procedure.

This product does NOT determine if you had 

COVID-19 in the past or if you have immunity.

Store the kit at 36~86°F/2~30°C. 76mm 18mm

165mm

Pre-made hole for tube

Scan for 

instructions and timer

Fast Results

At Home OTC

COVID-19 Ag Test

As an aid in the diagnosis 

of current COVID-19 

If you are concerned that

you have been exposed to 

COVID-19

With or without symptoms 

DO USE

On anyone under 2 years of 

age

If you are prone to nosebleeds

If you have had a facial or

head injury/surgery in the 

last 6 months

DO NOT USE

CO291-2

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.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 vitrodiagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of theFederal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

This product has been authorized only for the detection of proteins from 

SARS-CoV-2, not for any other viruses or pathogens.

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 technical support, please call: +1 (858)333-1122

FOR in vitro diagnostic use only

UDI

• 

• 

• • 

UPC

Use within 1 hour after opening the foil test cassette pouch

For most current shelf-life information of this test lot, please refer to the following link: http://www.fda.gov/covid-tests

For Use under FDA Emergency 

Use Authorization (EUA) only
4 Tests

Store the kit at 36~86°F/2~30°C.

76mm 30mm

165mm

The CorDx COVID-19 Ag Test is intended for the qualitative 

detection of SARS-COV-2 nucleocapsid protein antigen in 

anterior nasal (nares) swab samples.

COVID-19 Ag Test 

Read the QRI and instructions fully and carefully 

before performing the procedure.

Pre-made hole for tube

Fast Results

At Home OTC

COVID-19 Ag Test

As an aid in the diagnosis 

of current COVID-19 

If you are concerned that

you have been exposed to 

COVID-19

With or without symptoms 

DO USE

On anyone under 2 years of 

age

If you are prone to nose-

bleeds

If you have had a facial or

head injury/surgery in the 

last 6 months

DO NOT USE

FOR technical support, please call: +1 (858)333-1122

Manufacturing sites: CorDx, Inc.8940 Kenamar Dr, San Diego, CA 92121, 3719 North Peachtree Rd, Suite 200, Chamblee, GA 30341Core Technology Co., Ltd.No.30, Area 9, Douda Avenue, Fangshan District, Beijing 102433, China

TEST COMPONENTS: 4 Test cassettes 4 Swabs 4 Tubes with sample processing solution2 Tube holders (back of box) 1 Instructions for use

CorDx, Inc. 9540 Waples St Unit C, San Diego, CA 92121Web: CorDx.comEmail: info@CorDx.com

FOR in vitro diagnostic use only

This product 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.

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. 

• 

• 

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.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 vitrodiagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of theFederal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

• • 

Use within 1 hour after opening the foil test cassette pouch

Scan for 

instructions and timer

UPC UDI

For Use under FDA Emergency 

Use Authorization (EUA) only

For most current shelf-life information of this test lot, please refer to the following link: http://www.fda.gov/covid-tests

CO291-4
5 Tests

Store the kit at 36~86°F/2~30°C.

76mm 36mm

COVID-19 Ag Test 

Pre-made hole for tube

Fast Results

At Home OTC

COVID-19 Ag Test

As an aid in the diagnosis 

of current COVID-19 

If you are concerned that

you have been exposed to 

COVID-19

With or without symptoms 

DO USE

On anyone under 2 years of 

age

If you are prone to nose-

bleeds

If you have had a facial or

head injury/surgery in the 

last 6 months

DO NOT USE

FOR technical support, please call: +1 (858)333-1122

Manufacturing sites: CorDx, Inc.8940 Kenamar Dr, San Diego, CA 92121, 3719 North Peachtree Rd, Suite 200, Chamblee, GA 30341Core Technology Co., Ltd.No.30, Area 9, Douda Avenue, Fangshan District, Beijing 102433, China

TEST COMPONENTS: 5 Test cassettes 5 Swabs 5 Tubes with sample processing solution2 Tube holders (back of box) 1 Instructions for use

CorDx, Inc. 9540 Waples St Unit C, San Diego, CA 92121Web: CorDx.comEmail: info@CorDx.com

FOR in vitro diagnostic use only

The CorDx COVID-19 Ag Test is intended for the qualitative 

detection of SARS-COV-2 nucleocapsid protein antigen in 

anterior nasal (nares) swab samples.

Read the QRI and instructions fully and carefully 

before performing the procedure.

This product 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.

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. 

• 

• 

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.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 vitrodiagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of theFederal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

• • 

Use within 1 hour after opening the foil test cassette pouch

Scan for 

instructions and timer

UPC UDI

For Use under FDA Emergency 

Use Authorization (EUA) only

For most current shelf-life information of this test lot, please refer to the following link:http://www.fda.gov/covid-tests

CO291-5
Fast Results

170mm 65mm

84mm

The CorDx COVID-19 Ag Test is intended for the qualitative detection of SARS-COV-2 

nucleocapsid protein antigen in anterior nasal (nares) swab samples.

COVID-19 Ag Test 

Read the QRI and instructions fully and carefully before performing the 

procedure.

This product does NOT determine if you had COVID-19 in the past or if 

you have immunity.

CO291-10

FOR in vitro diagnostic use only.

FOR technical support, 

please call: +1 (858)333-1122

Store the kit at 36~86°F/2~30°C.

10 Tests

At Home OTC

COVID-19 Ag Test

Pre-made hole for tube

This product has been authorized only for the detection of proteins from SARS-CoV-2, 

not for any other viruses or pathogens.

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. 

CorDx, Inc. 

9540 Waples St Unit C, San Diego, CA 92121

Web: CorDx.com

Email: info@CorDx.com

TEST COMPONENTS: 

10 Test cassettes 

10 Swabs 

10 Tubes with sample processing solution

 2 Tube holders (back of box) 

 1 Instructions for use

Manufacturing sites: 

CorDx, Inc.

8940 Kenamar Dr, San Diego, CA 92121, 

3719 North Peachtree Rd, Suite 200, Chamblee, GA 30341

Core Technology Co., Ltd.

No.30, Area 9, Douda Avenue, Fangshan District, 

Beijing 102433, China

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

approved, but has been authorized by FDA under an 

EUA.

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.

••

• 

• 

Use within 1 hour after opening the foil test cassette pouch

Scan for 

instructions and timer

UPC UDI

For Use under FDA Emergency Use Authorization (EUA) only

For most current shelf-life information of this 

test lot, please refer to the following link: 

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

As an aid in the diagnosis of 

current COVID-19

If you are concerned that you have 

been exposed to COVID-19

With or without symptoms 

DO USE

On anyone under 2 years of age

If you are prone to nosebleeds

If you have had a facial or head 

injury/surgery in the last 6 months

DO NOT USE
200mm 132mm

84mm

COVID-19 Ag Test 

This product does NOT determine if you had COVID-19 in the past or if 

you have immunity.

Fast Results

20 Tests

At Home OTC

Ag Test COVID-19 

Pre-made hole for tube

CorDx, Inc. 

9540 Waples St Unit C, San Diego, CA 92121

Web: CorDx.com

Email: info@CorDx.com

Manufacturing sites: 

CorDx, Inc.

8940 Kenamar Dr, San Diego, CA 92121, 

3719 North Peachtree Rd, Suite 200, Chamblee, GA 30341

Core Technology Co., Ltd.

No.30, Area 9, Douda Avenue, Fangshan District, Beijing 102433, China

TEST COMPONENTS: 

20 Test cassettes 

20 Swabs 

20 Tubes with sample processing solution 

 2 Tube holders (Back of box) 

 1 Instructions for Use

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

approved, but has been authorized by FDA under an 

EUA.

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.

Store the kit at 36~86°F/2~30°C.

Use within 1 hour after opening the foil test cassette pouch

UPC

•

•

The CorDx COVID-19 Ag Test is intended for the qualitative detection of SARS-COV-2 

nucleocapsid protein antigen in anterior nasal (nares) swab samples.

Read the QRI and instructions fully and carefully before performing the 

procedure.

This product has been authorized only for the detection of proteins from SARS-CoV-2, 

not for any other viruses or pathogens.

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. 

• 

• 

Scan for 

instructions and timer

UDI

CO291-20

FOR in vitro diagnostic use only.

FOR technical support, 

please call: +1 (858)333-1122

For most current shelf-life information of this 

test lot, please refer to the following link: 

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

For Use under FDA Emergency Use Authorization (EUA) only

As an aid in the diagnosis of 

current COVID-19

If you are concerned that you have 

been exposed to COVID-19

With or without symptoms 

DO USE

On anyone under 2 years of age

If you are prone to nosebleeds

If you have had a facial or head 

injury/surgery in the last 6 months

DO NOT USE
••

Fast Results

180mm 75mm

84mm

COVID-19 Ag Test 

This product does NOT determine if you had COVID-19 in the past or if 

you have immunity.

Store the kit at 36~86°F/2~30°C.

12 Tests

At Home OTC

COVID-19 Ag Test

Pre-made hole for tube

The CorDx COVID-19 Ag Test is intended for the qualitative detection of SARS-COV-2 

nucleocapsid protein antigen in anterior nasal (nares) swab samples.

Read the QRI and instructions fully and carefully before performing the 

procedure.

This product has been authorized only for the detection of proteins from SARS-CoV-2, 

not for any other viruses or pathogens.

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. 

• 

• 

Manufacturing sites: 

CorDx, Inc.

8940 Kenamar Dr, San Diego, CA 92121, 

3719 North Peachtree Rd, Suite 200, Chamblee, GA 30341

Core Technology Co., Ltd.

No.30, Area 9, Douda Avenue, Fangshan District, 

Beijing 102433, China

TEST COMPONENTS: 

12 Test cassettes 

12 Swabs 

12 Tubes with sample processing solution

 2 Tube holders (back of box) 

 1 Instructions for use

CorDx, Inc. 

9540 Waples St Unit C, San Diego, CA 92121

Web: CorDx.com

Email: info@CorDx.com

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

approved, but has been authorized by FDA under an 

EUA.

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. Use within 1 hour after opening the foil test cassette pouch

Scan for 

instructions and timer

UPC UDI

CO291-12

FOR in vitro diagnostic use only.

FOR technical support, 

please call: +1 (858)333-1122

For most current shelf-life information of this 

test lot, please refer to the following link: 

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

For Use under FDA Emergency Use Authorization (EUA) only

As an aid in the diagnosis of 

current COVID-19

If you are concerned that you have 

been exposed to COVID-19

With or without symptoms 

DO USE

On anyone under 2 years of age

If you are prone to nosebleeds

If you have had a facial or head 

injury/surgery in the last 6 months

DO NOT USE
Fast Results

8 Tests

At Home OTC

COVID-19 Ag Test

160mm 55mm

84mm

COVID-19 Ag Test 

This product does NOT determine if you had COVID-19 in the past or if 

you have immunity.

Store the kit at 36~86°F/2~30°C.

CorDx, Inc. 

9540 Waples St Unit C, San Diego, CA 92121

Web: CorDx.com

Email: info@CorDx.com

Manufacturing sites: 

CorDx, Inc.

8940 Kenamar Dr, San Diego, CA 92121, 

3719 North Peachtree Rd, Suite 200, Chamblee, 

GA 30341

Core Technology Co., Ltd.

No.30, Area 9, Douda Avenue, Fangshan District, 

Beijing 102433, China

Pre-made hole for tube

Use within 1 hour after opening 

the foil test cassette pouch

TEST COMPONENTS: 

8 Test cassettes 

8 Swabs 

8 Tubes with sample processing solution

2 Tube holders (back of box) 

1 Instructions for use

For Use under FDA Emergency Use Authorization (EUA) only

••

In the USA, this product has not been FDA 

cleared or approved, but has been authorized by 

FDA under an EUA.

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 CorDx COVID-19 Ag Test is intended for the qualitative detection of SARS-COV-2 

nucleocapsid protein antigen in anterior nasal (nares) swab samples.

Read the QRI and instructions fully and carefully before performing the 

procedure.

This product has been authorized only for the detection of proteins from SARS-CoV-2, 

not for any other viruses or pathogens.

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. 

• 

• 

Scan for 

instructions and timer

UPC UDI

CO291-8

FOR in vitro diagnostic use only.

FOR technical support, 

please call: +1 (858)333-1122

For most current shelf-life information of this 

test lot, please refer to the following link: 

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

As an aid in the diagnosis of 

current COVID-19

If you are concerned that you have 

been exposed to COVID-19

With or without symptoms 

DO USE

On anyone under 2 years of age

If you are prone to nosebleeds

If you have had a facial or head 

injury/surgery in the last 6 months

DO NOT USE