www.fda.gov

Individuals using assistive technology may not be able to fully 

access the information contained in this document. For 

assistance, please call 1(800) 638-2041 or (301) 796-7100 or 

send an email to CDRH’s Division of Industry and Consumer 

Education (DICE). Please include “508 Accommodation” and 

the title of the document in the subject line of your e-mail.
BinaxNOWTM

ANTIGEN SELF TEST

COVID-19

INSTRUCTIONS

INTENDED USE

The BinaxNOWTM COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection 

of nucleocapsid protein antigen from SARS-CoV-2.

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

individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals 2 years or 

older. This test is authorized for individuals with symptoms of COVID-19 within the first seven 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 BinaxNOW COVID-19 Antigen Self 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) swabs 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. The agent 

detected may not be the definite cause of disease. Individuals who test positive with the BinaxNOW COVID-19 

Antigen Self Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional 

testing may be necessary.

All negative results should be treated as 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-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 healthcare provider. 

Individuals should provide all results obtained with this product to their healthcare provider in order 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 BinaxNOW COVID-19 Antigen Self Test is intended for non-prescription self-use and/or, as applicable for an 

adult lay user testing another person aged 2 years or older in a non-laboratory setting. The BinaxNOW COVID-19 

Antigen Self 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 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. Turn Over

TEST KIT COMPONENTS OVERVIEW

! Do not open any parts before reading instructions.

FREQUENTLY ASKED QUESTIONS

What are the Known and Potential Risks and Benefits of this Test?

Potential Risks Include:

• Possible discomfort during sample collection.

• Possible incorrect test results (see Results section).

Potential Benefits Include:

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

about your care.

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

For more information on EUAs go here: https://www.fda.gov/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/emergencyuse-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 BinaxNOW COVID-19 

Antigen 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 available at www.globalpointofcare.eifu.abbott.

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.

LIMITATIONS 

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

collected between January, 2021, 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 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.

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.

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

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

WARNINGS, PRECAUTIONS and SAFETY INFORMATION

1. For in vitro diagnostic use.

2. Wear safety mask or other face covering when collecting anterior nares swab specimen from a child or

another individual.

3. Use of gloves is recommended when conducting testing.

4. Keep testing kit and kit components out of the reach of children and pets before and after use.

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

EUA.

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

viruses or pathogens.

7. 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.

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

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

10. Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or open. Once

opened, the test card should be used immediately.

11. Do not dip the swab into the liquid reagent or other liquid before inserting the swab into the nose.

12. Do not touch swab tip when handling the swab sample.

13. Do not use kit past its expiration date.

14. Do not mix components from different kit lots.

15. All kit components are single use items. Do not use with multiple specimens. Do not reuse the used test card.

16. Dispose of kit components and patient samples in household trash.

17. INVALID RESULTS can occur when an insufficient volume of extraction reagent is added to the test card. To

ensure delivery of adequate volume, hold bottle vertically, 1/2 inch above the swab well, and add drops slowly.

18. 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.

EN

ENGLISH

Testing supplies are provided in each box. 

Test Kit Contains:

Swab Test Card in Pouch Dropper Bottle

BinaxNOWTM

COVID-19 Ag CARD

SAMPLE

CONTROL or

WHAT YOUR RESULTS MEAN

Positive Result

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 wrong (a false positive result). 

Negative Result

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 Result

An invalid result means this test was unable to determine whether you have COVID-19 or not. Re-test with 

a new swab and new test device. Please contact Technical Support at + 1 833-637-1594.

For Use Under an Emergency Use Authorization (EUA) Only

For use with anterior nasal swab specimens 

For in vitro Diagnostic Use Only

19. An anterior nasal swab sample can be self-collected by an individual age 15 years and older. Children age 2 to

15 years should be tested by an adult.

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

days with at least 48 hours between tests.

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

22. Do not read test results before 15 minutes or after 30 minutes. Results read before 15 minutes or after 30

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

23. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests.

This means that there is a higher chance this test will give you a negative result when you have COVID-19.

24. The Reagent Solution contains a harmful chemical (see table below). Do not ingest any kit components. If 

the solution contacts the skin or eye, flush with copious amounts of water. If irritation persists, seek medical

advice: www.poisonhelp.org or 1-800-222-1222.

Chemical Name/CAS GHS Code for each Ingredient Concentration

Sodium Azide/26628-22-8 Acute Tox. 2 (Oral), H300

Acute Tox. 1 (Dermal), H310

0.0125%

For more information on EUAs please visit: https://www.fda.gov/emergencypreparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergencyuse-authorization

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

STORAGE and STABILITY 

Store kit between 35.6-86°F (2-30°C). Ensure all test components are at room temperature before use. 

The BinaxNOW COVID-19 Antigen Self Test is stable until the expiration date marked on the outer packaging 

and containers. For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, 

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

Read all instructions carefully before performing the test. Failure to follow the 

instructions may result in inaccurate test results.

Test Card Parts:

Result Window

1

2

3

Top Hole

Test Strip Lower Hole

Top

Bottom

Outside of Card Inside of Card

INSTRUCTIONS - START HERE

Carefully read instructions prior to starting test. 

It is recommended gloves (not provided) also be used 

during testing. See other side for important information. 

BEFORE STARTING

1. Wash or sanitize your hands.

Make sure they are dry 

before starting.

A. PREPARE FOR THE TEST

Your box may contain more than one test kit.

Use only 1 of each of the following for each test:

BinaxNOWTM

COVID-19 Ag CARD

SAMPLE

CONTROL

1 Dropper Bottle Timing Device

(not included)

1 Swab 1 Test Card in Pouch

or

! DO NOT touch any parts on the inside. Handle card only by edges.

1

2

3

Result Window Top Hole Test Strip Lower Hole

Top

Bottom

Outside of Card Inside of Card

2. Remove test card from pouch.

Make sure the blue control 

line is present in the result

window. Do not use the card if 

it is not.

SAMPLE

CONTROL

Open the card and lay it flat 

on the table with the pink 

side down. You may bend 

the spine in the opposite 

direction to help the card 

lay flat. DO NOT touch the test strip.

! Card must stay FLAT on table for entire test.

3. Remove dropper bottle cap.

Hold dropper bottle straight 

over top hole, not at an angle.

Put 6 drops into top hole.

Do not touch card with tip.

6 drops

Note: False negative result may occur if more 

than 6 drops of fluid are put in the hole. 

Abbott Rapid Diagnostics

Technical Support

US 

+ 1-833-637-1594 

ts.scr@abbott.com

Abbott Diagnostics Scarborough, Inc. 

10 Southgate Road

Scarborough, Maine 04074 USA

www.globalpointofcare.abbott

© 2023 Abbott. All rights reserved.

All trademarks referenced are trademarks of either the 

Abbott group of companies or their respective owners.

IN195150 Rev. 7 2023/11

SAP: 40003868

Visit www.globalpointofcare.abbott/us/en/support/

binaxnow-covid-19-antigen-self-test-us.html 

to report your results and view instructions for use.
C. PERFORM THE TEST continued

! DO NOT remove swab.

8. Peel adhesive liner off. Be 

careful not to touch other 

parts of card.

a Peel

Close left side of the card 

over swab. Press firmly on 

the two lines on right edge of 

the card to seal. 

Keep card face up on table.

b Seal

! DO NOT move or touch the card during this time. 

9. Wait 15 minutes. 

Read the result at 15 minutes. 

Do not read the result 

before 15 minutes or after 

30 minutes. 

WAIT

15 MINUTES

READ

BETWEEN 

15-30 MINUTES

15

min

Note: A control line may appear in the result window in a few minutes 

but a sample line may take as long as 15 minutes to appear.

Note: Results should not be read after 30 minutes.

C. PERFORM THE TEST

! Keep card FLAT on table.

6. Insert swab tip into 

lower hole. 

Firmly push the swab tip from 

the lower hole until 

it is visible in the top hole. 

Do not remove the swab from 

the card. 

7. Turn swab to right 3 times 

to mix the swab with 

the drops. 

Do not skip this step. 

Leave the swab in the card for 

the remainder of the test.

Note: False negative result can occur if swab is not turned. 

3x

B. COLLECT NASAL SAMPLE

! Keep fingers away from the swab end.

4. Open swab package at stick 

end. Take swab out. 

5. Swab both nostrils carefully 

as shown.

Insert the entire soft tip of the 

swab into a nostril (usually 1/2 

to 3/4 of an inch). 

You do not need to go deeper. 

a Up to 3/4 of an inch

Using medium pressure, rub 

the swab against all of the 

inside walls of your nostril. 

Make at least 5 big circles. 

Do not just spin the swab. 

Each nostril must be swabbed 

for about 15 seconds.

b At least 5 big circles

Using the same swab, repeat 

step 5 in your other nostril. c At least 5 big circles

Note: False negative result may occur if the nasal swab is not 

properly collected.

Check: 

Did you swab 

BOTH nostrils?

D. INTERPRET RESULTS

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

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.

Check for Positive COVID-19 Result

Find result window and look carefully for two pink/purple lines.

Positive Result: If you see two pink/purple lines (one on the top half and 

one on the bottom half), this means COVID-19 was detected.

Look very closely! 

The bottom line 

can be very faint. 

Any pink/purple 

line visible here is a 

Positive Result.

CONTROL

SAMPLE

Positive Positive

Solid Line Faint Line

OR

Solid Line

Positive

Faint Line

Positive

Actual photos of positive 

tests. On the right, note how 

faint the bottom line can get.

You do not need to perform repeat testing if you have a positive result 

at any time.

E. DISPOSE THE TEST KIT

Throw away all used test kit components 

in the trash. BinaxNOWTM

COVID-19 Ag 

CARD

SAMPLE

CONTROL

D. INTERPRET RESULTS continued

Check for Negative COVID-19 Result

Find result window and look for a 

single pink/purple line in window.

Negative Result: If you see only

one pink/purple line on the top half, 

where it says “ Control„ this means 

COVID-19 was not detected. No Line

Negative

No Line

Negative

CONTROL

SAMPLE

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.

Check for Invalid Result

If you see any of these, the test is invalid. An invalid result means this 

test was unable to determine whether you have COVID-19 or not. A 

new test is needed to get a valid result.

Please contact Technical Support at + 1-833-637-1594.

No lines seen Blue control

line only

Pink/purple

sample line only

Blue control line AND

pink/purple sample line No lines seen Blue controlline only

Pink/purple

sample line only

Blue control line AND

pink/purple sample line No lines seen Blue controlline only

Pink/purple

sample line only

Blue control line AND

pink/purple sample line

CONTROL

SAMPLE

No lines seen Blue control

line only

Pink/purple 

sample line 

only

Blue control line 

AND pink/purple 

sample line No lines seen Blue control

line only

Pink/purple

sample line only

Blue control line AND

pink/purple sample line

Note: See other side to read about what your results mean. 

F. REPORT YOUR RESULTS

Visit www.globalpointofcare.abbott/us/en/support/

binaxnow-covid-19-antigen-self-test-us.html 

to report your results.
Abbott

BinaxNOW 

COVID-19 Antigen Self Test

OTC PI - EN

Size: 

Flat size: 17 in x 11 in

Folded size: 4.25 in x 5.50 in 

Note: 

Fold lines are not printed.

Printed Colors PN: IN195150

Rev: 7

SAP: 40003868 CMYK

Incoming Inspection Colors

Date of Last Revision: 

7.5 2023/11/15

PMS 2995 U

Primary Blue

PMS 224 U

Magenta-Pink

PMS 303 U

Dark Blue
MPV 11.3 FL

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

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

Contents:• 5 BinaxNOWTM COVID-19 Test Cards 

• 5 Nasal Swabs• 5 Reagent Bottles• 1 Patient InstructionsNot provided: • Timer

Abbott Diagnostics Scarborough, Inc.10 Southgate RoadScarborough, Maine 04074 USAwww.binaxnow-selftest.abbott

© 2023 Abbott. All rights reserved.All trademarks referenced are trademarksof either the Abbott group of companies or their respective owners.

195-1XX

PK1951XX-5T Rev. 2 2023/11

SAP: XXXX

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

195-1XX 5 OTC 2°C 30°C

FOR INFECTION DETECTION

ANTIGEN SELF TEST

COVID-19

For use under an Emergency 

Use Authorization only.

For in vitro diagnostic use

5TESTS

5TESTS

5TESTS

ANTIGEN

FOR INFECTION DETECTION

 SELF TEST

COVID-19

195-1XX OTC

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

FOR INFECTION DETECTION

ANTIGEN SELF TEST COVID-19

A Simple Nasal Swab

EASY

Results in 15 Minutes

FAST 15

Made in the USA

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 INFECTION DETECTION

 SELF TEST ANTIGEN COVID-19

FPO

Ages 2 and up

No

Ink/Varnish

Horizontal Grain

1+3/32 5+1/16 1+1/8 5+1/16 5/8

3/4

1+3/32

9+1/8

15/16

9+3/32

15/16

12+31/32

12+27/32

6+3/16

No Varnish

No Varnish

No Varnish

No Varnish

PMS 2925 C

Primary Blue

PMS 303 C

Dark Blue

C=0, M=9, 

Y=100, K=0

Abbott Yellow

CMYK PN: PK1951XX-5T

Rev: 2

SAP: XXXX

Date of Revision: 

2.2 2023/11/16

Abbott 

BinaxNOW 

COVID-19 Antigen

Self Test 5 Pack 

5 Tests

Dieline: 2T6

Dimensions:

9 3/32 in x 5 1/16 in x 1 1/8 in Cut Line

Do Not Print

Crease Line

Do Not Print

Visit www.globalpointofcare.abbott/us/en/support/binaxnow-covid-19-antigenself-test-us.html to report your results and view instructions for use
•

Contents:

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

1 BinaxNOWTM COVID-19 Test Card 

• 1 Nasal Swab• 1 Reagent Bottle•Not provided:

 1 Patient Instructions

• Timer or their respective owners. of either the Abbott group of companies 

All trademarks referenced are trademarks© 2023 Abbott. All rights reserved.

www.binaxnow-selftest.abbottScarborough, Maine 04074 USA10 Southgate RoadAbbott Diagnostics Scarborough, Inc.

195-140

PK195140 Rev. 3 2023/11

SAP: 40003867

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

ANTIGEN

FOR INFECTION DETECTION

SELF TEST

COVID-19

1 TEST

1 TEST

FOR INFECTION DETECTION

ANTIGEN SELF TEST

COVID-19

195-140 OTC

the authorization of emergency use of duration of the declaration that circumstances exist justifying The emergency use of this product is only authorized for the pathogens; and,proteins from SARS-CoV-2, not for any other viruses or This product has been authorized only for the detection of approved; but has been authorized by FDA under an EUA;In the USA, this product has not been FDA cleared or 

in vitro diagnostics for 

antigen tests, please refer to http://www.fda.gov/covid-testsFor more information on expiration dating for COVID-19 terminated or authorization is revoked sooner.U.S.C. § 360bbb-3(b)(1), unless the declaration is 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 detection and/or diagnosis of COVID-19 under Section 

FOR INFECTION DETECTION

ANTIGEN SELF TEST COVID-19

ANTIGEN

FOR INFECTION DETECTION

 SELF TEST COVID-19

EASYA Simple Nasal Swab

FASTResults in 15 Minutes 15

195-140 1 OTC 2 C° 30 C°

and view instructions for useself-test-us.html to report your results en/support/binaxnow-covid-19-antigenVisit www.globalpointofcare.abbott/us/

1 TEST

For use under an Emergency 

Use Authorization only.

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

For testing with or without symptoms

Made in the USA

Ages 2 and up

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

For in vitro diagnostic use

0.500 4.500 0.700 4.500 0.669

0.625

0.669

7.000

0.669

0.625

0.647

0.313

0.375

0.031

15

o

15

o

0.625

R

10.869

9.588

BLEED AREAS - SPECIFIED

NON COATED AREAS - SPECIFIED

0.360 1.750

0.330 1.250

DATE CODE

NO INK/

NO VARNISH

No Varnish

No Varnish

No Varnish

No Varnish

PMS 2925 C

Primary Blue

PMS 303 C

Dark Blue

C=0, M=9, 

Y=100, K=0

Abbott Yellow

CMYK PN: PK195140 

Rev: 3

SAP: 40003867

Date of Revision: 

3.3 2023/11/16

Abbott 

BinaxNOW 

COVID-19 Antigen

Self Test 1 Pack 

1 Test

Dieline: 2T7

Dimensions:

4.5 in x 7 in x 0.7 in

Cut Line

Do Not Print

Crease Line

Do Not Print
RDW SD 40.8 FL

MPV 11.3 FL

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

Contents:• 2 BinaxNOWTM COVID-19 Test Cards

• 2 Nasal Swabs• 2 Reagent Bottles• 1 Patient InstructionsNot provided:• Timer

Abbott Diagnostics Scarborough, Inc.10 Southgate RoadScarborough, Maine 04074 USAwww.binaxnow-selftest.abbott

© 2023 Abbott. All rights reserved.All trademarks referenced are trademarksof either the Abbott group of companies or their respective owners.

195-160

PK195160 Rev. 9 2023/11

SAP: 40003869 Store between 35.6-86° F (2-30° C) until use

195-160 2 OTC 2°C 30°C

FOR INFECTION DETECTION

ANTIGEN SELF TEST

COVID-19

For use under an Emergency 

Use Authorization only. 2TESTS

2TESTS

2TESTS

195-160 OTC

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

ANTIGEN

FOR INFECTION DETECTION

 SELF TEST

COVID-19

FOR INFECTION DETECTION

ANTIGEN SELF TEST COVID-19

ANTIGEN

FOR INFECTION DETECTION

 SELF TEST COVID-19

A Simple Nasal SwabEASY

Results in 15 MinutesFAST 15

Made in the USA

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 INFECTION DETECTION

 SELF TEST ANTIGEN COVID-19

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

For in vitro diagnostic use

Ages 2 and up

Visit www.globalpointofcare.abbott/us/en/support/binaxnow-covid-19-antigenself-test-us.html to report your results and view instructions for use

No

Ink/Varnish

0.906

1.219

7.000

1.219

0.906

11.250

1.219 4.325 1.250 4.325

11.744

0.625

0.414

R

0.031

1.750

1.250

0.430

0.300

0.056"

0.03"

0.039" 0.078"

OPTIONAL

WAVE PERF

GLUE ASSIST

CUT 50% THRU

0.414

R

0.031

R

0.414

R

0.414

R

1.062

PMS 2925 C

Primary Blue

PMS 303 C

Dark Blue

C=0, M=9, 

Y=100, K=0

Abbott Yellow

CMYK

PN: PK195160 

Rev: 9

SAP: 40003869

Date of Revision: 

9.7 2023/11/16

Abbott 

BinaxNOW 

COVID-19 Antigen

Self Test 2 Pack 

2 Tests

Dieline: 2T8

Dimensions:

4.325 in x 7 in x 1.25 in

Cut Line

Do Not Print

Crease Line

Do Not Print
RDW SD 40.8 FL

MPV 11.3 FL

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

Contents:• 4 BinaxNOWTM COVID-19 Test Cards

• 4 Nasal Swabs• 4 Reagent Bottles• 1 Patient InstructionsNot provided:• Timer

Abbott Diagnostics Scarborough, Inc.10 Southgate RoadScarborough, Maine 04074 USAwww.binaxnow-selftest.abbott

© 2023 Abbott. All rights reserved.All trademarks referenced are trademarksof either the Abbott group of companies or their respective owners.

195-180

PK195180 Rev. 6 2023/11

SAP: 40003871 Store between 35.6-86° F (2-30° C) until use

195-180 4 OTC 2°C 30°C

FOR INFECTION DETECTION

ANTIGEN SELF TEST

COVID-19

4TESTS

4TESTS

195-180 OTC

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

ANTIGEN

FOR INFECTION DETECTION

 SELF TEST

COVID-19

FOR INFECTION DETECTION

ANTIGEN SELF TEST COVID-19

ANTIGEN

FOR INFECTION DETECTION

 SELF TEST COVID-19

A Simple Nasal SwabEASY

Results in 15 MinutesFAST 15

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 INFECTION DETECTION

 SELF TEST ANTIGEN COVID-19

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

For in vitro diagnostic use

Ages 2 and up

For use under an Emergency 

Use Authorization only. 4TESTS

Visit www.globalpointofcare.abbott/us/en/support/binaxnow-covid-19-antigenself-test-us.html to report your results and view instructions for use

No

Ink/Varnish

0.906

1.219

7.000

1.219

0.906

11.250

1.219 4.325 1.250 4.325

11.744

0.625

0.031

1.750

1.250

0.430

0.300

0.056"

0.03"

0.039" 0.078"

OPTIONAL

WAVE PERF

GLUE ASSIST

CUT 50% THRU

0.031

R

1.062 No Varnish

No Varnish

No Varnish

No Varnish

PMS 2925 C

Primary Blue

PMS 303 C

Dark Blue

C=0, M=9, 

Y=100, K=0

Abbott Yellow

CMYK

PN: PK195180

Rev: 6

SAP: 40003871

Date of Revision: 

6.3 2023/11/16

Abbott 

BinaxNOW 

COVID-19 Antigen

Self Test 4 Pack 

4 Tests

Dieline: 2T8

Dimensions:

4.325 in x 7 in x 1.25 in

Cut Line

Do Not Print

Crease Line

Do Not Print
FOR INFECTION DETECTION

ANTIGEN SELF TEST

COVID-19

10 OTC 195-170 Store between 35.6-86° F (2-30° C) until use 2°C

30°C

10TESTS

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

Not provided:

• Timer 

Store between 35.6-86° F (2-30° C) until 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; and,

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.

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

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.

TESTS 10

Made in the USA

FOR INFECTION DETECTION

ANTIGEN SELF TEST COVID-19

PK195170 Rev. 5 2023/11

SAP: 40003870

195-170

© 2023 Abbott. All rights reserved.

All trademarks referenced are trademarks

of either the Abbott group of companies 

or their respective owners.

FOR INFECTION DETECTION

ANTIGEN SELF TEST COVID-19

Contents:

• 10 BinaxNOWTM COVID-19 Test Cards 

• 10 Nasal Swabs

• 10 Reagent Bottles

• 1 Patient Instructions

Abbott Diagnostics Scarborough, Inc.

10 Southgate Road

Scarborough, Maine 04074 USA

www.binaxnow-selftest.abbott

COVID-19

EASY

A Simple Nasal Swab

FAST

Results in 15 Minutes 15

Ages 2 and up

FOR INFECTION DETECTION

SELF TEST ANTIGEN

EN

For use under an Emergency 

Use Authorization only.

 diagnostic use. in vitro For 

195-170 OTC

Visit www.globalpointofcare.abbott/us/

en/support/binaxnow-covid-19-antigenself-test-us.html to report your results 

and view instructions for use

NO PRINT/COATING

NO PRINT/COATING

281/

4

1113/

16

0.518R

0.518R

Copy

Free

Copy

Free

Copy

Free

Copy

Free

No Ink

Glue Area

Glue Area

No Ink

Glue Area

No Ink

No Ink

No Ink

PMS 2925 C

Primary Blue

PMS 303 C

Dark Blue

CMYK

PN: PK195170 

Rev: 5

SAP: 40003870

Date of Last Revision: 

5.3 2023/11/16

Abbott 

BinaxNOW 

COVID-19 Antigen

Self Test OTC 10 Pack 

10 Tests

Dieline: LG6

Dimensions:

8 5/16 in x 4 15/16 in x 2 3/16 in

Cut Line

Do Not Print

Crease Line

Do Not Print

C=0, M=9, 

Y=100, K=0

Abbott Yellow

No

Ink/Varnish