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REF 33301

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Test

REF IVD OTC 1 33301

Cosmetic Act, 21 U.S.C. use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Federal Food, Drug and this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has 

ξ 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 

COVID-19 Antigen

FPO (UPC)

COVID-19 Antigen

· For· For Emergency Use Authorization (EUA) only

 in vitro diagnostic use

• 1 Status

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TM COVID-19 Antigen Rapid Test for Home Use

• 1 Quick Reference Instructions• 1 Test Solution Capsule• 1 Nasal Swab

Contents:

Scan QR code with phone camera to learn more.

SWAB

ID

DATE

COVID-19 Ag

Status

TEST

Status

COVID-19 Ag

Ctrl

CoV19

READ

P-4386 Rapid Test for Home Use COVID-19 Antigen

Rapid Test for Home Use

800-xxx-xxxx

CoV19

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

NO VARNISH

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for Userefer to Instructions For symbol glossary, 

Rapid Test for Home Use
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REF 33302

• Simple & Easy Nasal Swab • Results in 15 Minutes

Tests

COVID-19 Antigen

FPO (UPC)

COVID-19 AntigenScan QR code with phone camera 

to learn more.

SWAB

ID

DATE

COVID-19 Ag

Status

TEST

Status

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CoV19

READ

P-4387 Rapid Test for Home Use COVID-19 Antigen

Rapid Test for Home Use

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Cosmetic Act, 21 U.S.C. use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Federal Food, Drug and this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has 

ξ 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 

· For· For Emergency Use Authorization (EUA) only

 in vitro diagnostic use

• 2 Status

 visit https://www.fda.gov/covid-tests· For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, · Items necessary to use the kit but not provided: Timer· For ages 2 and up 

TM COVID-19 Antigen Rapid Test for Home Use

• 1 Quick Reference Instructions• 2 Test Solution Capsule• 2 Nasal Swab

Contents:

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

Rapid Test for Home Use
FPO (UPC)

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CoV19

25

33325 REF

• Simple & Easy Nasal Swab 

• Results in 15 Minutes

Tests

COVID-19 Antigen

Scan QR code with phone camera 

to learn more.

Rapid Test for Home Use

COVID-19 Antigen

Rapid Test for Home Use

COVID-19 Antigen

Rapid Test for Home Use

SWAB

ID

DATE

COVID-19 Ag

Status

TEST

Status

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NO VARNISH

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, 

not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. ξ 360bbb-3(b)(1), unless the declaration is terminated 

or authorization is revoked sooner. 

· For Emergency Use Authorization (EUA) only

· For in vitro diagnostic use

· For ages 2 and up 

· Items necessary to use the kit but not provided: Timer

· For information about current expiration dates for at-home OTC COVID-19 diagnostic tests, visit https://www.fda.gov/covid-tests

• 25 StatusTM COVID-19 Antigen Rapid Test for Home Use

• 25 Nasal Swab

• 25 Test Solution Capsule

• 1 Quick Reference Instructions

Contents:

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.

IVD OTC REF

25 33325

For symbol glossary, 

refer to Instructions 

for Use
ID

DATE

COVID-19 Ag

Status

ID

DATE

COVID-19 Ag

Status

SQUEEZE CoV19 Ctrl

StatusTM COVID-19 Antigen 

Rapid Test for Home Use

The test kit contains these items:

You will also need a clock or timer which is not included. Slowly rotate the swab in a circular motion 5 times by firmly 

pressing against the inside walls of the nostril. 

Do not just spin the swab. Gently remove the swab and repeat 

in the second nostril using the same swab.

NEGATIVE RESULT

5x 5x

+

LEFT SIDE RIGHT SIDE

After 1 minute, rotate the swab 

3 times again. 

If the Control (Ctrl) line is visible, but the Test 

(CoV19) 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. 

If a pink/purple test line (CoV19) is visible together with a control line (Ctrl), this means that the 

result is positive. Any faint visible pink/purple test 

line (CoV19) with a control line (Ctrl) 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 that 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 (Ctrl) line is not visible at 15 minutes, 

the test is invalid. Re-test with a new swab and 

new test device.

Slowly lay the device back 

down on the flat surface 

and set a timer for 15 

minutes. Do not move the 

device during this time.

 

1 PREPARE TEST

Open the foil pouch and remove the test device and lay it on a 

flat surface.

 

2 OPEN REAGENT CAPSULE

Twist the tab at the top.

3 ADD REAGENT

Hold the capsule directly over the Extraction Well and squeeze 

all of the reagent into the well. Discard the empty capsule in the 

trash.

4 OPEN SWAB

Open the swab wrapper at the stick end. Be careful not to touch 

the swab tip.

 5 SWAB NOSTRILS

8 ROTATE SWAB AGAIN

 

9 RAISE DEVICE TO STAND

Slowly raise the device to stand upright and let stand for 3 

seconds. The reagent will flow into the hole in the Test 

Well. Failure to let the device stand upright for 3 seconds 

may result in an invalid test result.

 

10 LAY DEVICE DOWN

READ TEST RESULTS AT 15 MINUTES

WARNING! Results may be inaccurate if read before 15 

minutes or after 20 minutes.

Look at the Result Window and locate the Ctrl and the 

CoV19 on the side of the window. A pink/purple color line 

should always appear at the Ctrl position. This is a control line 

and shows that the test is working properly.

WARNING! Inaccurate test results may occur if the nasal swab 

specimen is not properly collected.

For test accuracy, make sure to collect sample from both 

nostrils. 

NOTE: A nasal swab sample can be self-collected by persons 

aged 14 and older. Children aged 2-13 should be tested by 

an adult. With children, you may not need to insert the swab 

as far into the nostril. For very young children, you may need 

another person to steady the child’s head while swabbing. 

Please wear a face mask when swabbing others.

WARNING! If any reagent 

spills out of the test device, 

the test will be invalid and 

you will need to perform 

another test.

Holding the stick end of 

the swab, gently insert 

the swab tip into the 

nostril no more than 

1/2–3/4 in.

POSITIVE RESULT

INVALID RESULT

Storage and Stability

• Store at 2–30°C/36–86°F, away from direct sunlight.

• Do not freeze.

• Do not use past the expiration date indicated on the

external packaging.

For use with anterior nasal swab specimens

In vitro diagnostic use

For Emergency Use Authorization (EUA) only

Carefully read the complete instructions before starting 

the test. Failure to follow the instructions may result in 

inaccurate test results. Wash your hands with soap and 

water or use hand sanitizer and dry thoroughly.

Read test results at 15 minutes.

Discard the swab in the trash.

Quick Reference Guide

WARNING! Results may be 

inaccurate if the swab is not 

rotated and left in place for 1 

minute.

Status

COVID-19 Ag

CoV19Ctrl

33125

Skillman, NJ, USA

PBM Monmouth Junction, NJ, USA

EC REP MT Promedt Consulting GmbH, St. Ingbert, Germany 

COVID-19 Ag

TM

DIST

StatusTM COVID-19 Antigen Test

Instructions for use

Test device in foil pouch 

QRG Swab in wrapper

Reagent capsule

Swab 

Stand

Extraction Well Result Window

Test Control

Swab tip

ID

DATE

COVID-19 Ag

Status

CoV19

Ctrl

ID

DATE

COVID-19 Ag

Status

3x

CoV19

Ctrl

1 MINUTE

ID

DATE

COVID-19 Ag

Status

3x

CoV19

Ctrl

ID

DATE

COVID-19 Ag

Status

ID

DATE

COVID-19 Ag

Status

CoV19

Ctrl

CoV19

Ctrl

15 MINUTES

ID

DATE

COVID-19 Ag

Status

ID

DATE

COVID-19 Ag

Status

CoV19

Ctrl

CoV19

Ctrl

Status

COVID-19 Ag

Ctrl

CoV19

Control

Test

Ctrl

CoV19

Ctrl

CoV19

Ctrl

CoV19

Ctrl

CoV19

Ctrl

CoV19

Ctrl

CoV19

Ctrl

CoV19

ID

DATE

COVID-19 Ag

Status

ID

DATE

COVID-19 Ag

Status

CoV19

Ctrl

6 INSERT SWAB TIP

Insert the swab tip into the Swab Stand in the Extraction Well 

where you previously added the reagent.

WARNING! False negative results may occur if all sample 

extraction reagent is not added to the Extraction Well or 

spilled during the addition to the Extraction Well.

Do not touch the result window or the Extraction Well of the 

test device.

Do not add sample to the rectangular result window.

 7 ROTATE SWAB

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

understand COVID-19 spread in your area and across the country 

and informs public health decisions.

Rotate the swab 3 times to 

mix the sample. 

Leave the swab in place.

Set a timer for 1 minute.
Repeat testing is needed to improve test accuracy. Please follow the table below 

when interpreting test results.

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.

The StatusTM COVID-19 Antigen Rapid Test for Home Use is a lateral flow 

immunoassay device intended for the qualitative detection of nucleocapsid 

protein antigen from SARS-CoV-2.

The StatusTM COVID-19 Antigen Rapid Test for Home Use 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 definitive cause of disease. Individuals who test positive with the 

StatusTM COVID-19 Antigen Rapid Test for Home Use 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 StatusTM COVID-19 Antigen Rapid Test for Home Use 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 StatusTM COVID-19 

Antigen Rapid Test for Home Use is only for in vitro diagnostic use under the 

Food and Drug Administration’s Emergency Use Authorization. This product has 

not been FDA cleared or approved.

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 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. 

• 

• 

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

authorized by FDA under an Emergency Use Authorization. This product has

been authorized only for the detection of proteins from SARS-CoV-2, not for

any other viruses or pathogens. The emergency use of this product is only

authorized for the duration of the declaration that circumstances exist

justifying the authorization of emergency use of in vitro diagnostics for

detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the

declaration is terminated, or authorization is revoked sooner. 

Serial testing should be performed in individuals with negative results

at least twice over three days (with 48 hours between tests) for

symptomatic individuals and three times over five days (with at least 48

hours between tests) for asymptomatic individuals. You may need to

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

have had symptoms longer than 5 days you should consider testing at

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

• If you skip a step or perform a step incorrectly, discard the test device, start

over with a new test and make sure to perform all steps correctly.

• An anterior nasal swab sample can be self-collected by an individual age 14 

years and older. Children age 2 to 13 years should be tested by an adult.

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

• Wear a safety mask or other face-coverings when collecting a specimen from

a child or another individual.

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

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

• Do not touch the swab tip.

• Leave the test device sealed in its pouch until just before use. Once opened,

the test device should be used within 60 minutes.

• Do not use the test after the expiration date shown on the external

packaging.

• Ensure that there is sufficient lighting for testing and interpretation.

• This test may give false negative results when tested in conditions of <15%

humidity.

• Do not use nasal sprays for at least 30 minutes before collecting a nasal

sample.

• The use of some hand sanitizer lotions may affect the results of the test.

Please ensure your hands are dry before performing the test.

• Remove any piercings from the nose before starting the test.

• Do not use on anyone who is prone to nosebleeds or has had facial injuries or

head injuries/surgery in the past six months.

• 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.

• Keep testing kit and kit components away from children and pets before and

after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest

any kit component. The Reagent solution contains a harmful chemical (see

table below). If contact with the body occurs, flush with a copious

amount of water. If irritation persists, seek medical advice. https://

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

• For more information on EUAs please visit: "https://www.fda.gov/

emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization"

• For the most up to date information on COVID-19, please 

visit: "http://www.cdc.gov/COVID19”

• 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 January 2023 -

February 2023. 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. 

• These test results are shown as lines of color. Because these lines can be very

faint, users with conditions affecting their vision - such as far-sightedness,

glaucoma, or color blindness - are encouraged to seek assistance to interpret

results accurately (e.g., reading glasses, additional light source, or another

person).

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

handled.

• 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.

Q: WHAT ARE THE KNOWN POTENTIAL RISKS AND BENEFITS OF THIS TEST?

A: Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test results (see Warnings and Result Interpretation

sections for more information).

Potential benefits include:

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

provider make informed recommendations about your care.

• The results of this test may help limit the potential spread of COVID-19 to

your family and others in your community.

For more information on EUAs go here: https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency- use-authorization

Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR 

TEST?

A: There are different kinds of tests for the virus that causes COVID-19. Molecular 

tests detect genetic material from the virus. Antigen tests, such as the StatusTM 

COVID-19 Antigen Rapid Test for Home Use, 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. 

Q: HOW ACCURATE IS THIS TEST?

A: Clinical studies have shown that antigen tests more accurately determine 

whether you are infected with the virus that causes COVID-19 when taken 

multiple times across several days. Repeat testing improves test accuracy. This 

serial testing approach is recommended to minimize the risk of incorrect results. 

For more information on the performance of the test and how the performance 

may apply to you, please refer to the performance data in the Healthcare 

Provider Instructions for Use (IFU), available at www.lifesignmed.com.

Q: WHAT IF I HAVE A POSITIVE TEST RESULT?

A: A positive result means 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. 

Q: WHAT IF I HAVE A NEGATIVE TEST RESULT?

A: 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.

Q: WHAT DOES AN INVALID TEST RESULT MEAN?

A: 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 the 

test should be run again, using all new test components.

IMPORTANT

Do not use this test as the only guide to managing your illness. Please 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.

Intended Use

How to Use This Test

Frequently Asked Questions

Index of Symbols

Help line: 1-800-526-2125

P-5386-E

Rev. 2023-04-25

Limitations

Chemical Name CAS GHS Code for Each Ingredient Concentration (%)

Sodium Azide 

26628-22-8

H300, Harmful if swallowed 

H310, Skin irritation 0.09%

0.2%

Triton X-100 

9036-19-5

H302, Harmful if swallowed

H315, Causes skin irritation 

H318, Causes serious eye damage 

H410, Very toxic to aquatic life with 

long-lasting effects

Serial Test Results Interpretation

Status on first 

day of testing

With 

Symptoms

Without 

Symptoms

Positive N/A N/A

N/A

N/A

N/A

N/A

N/A

Negative Positive

Negative Negative

Negative Positive

Positive

Negative

Negative

Negative Positive

Negative Negative

First Result

Day 1

First Result

Day 1

First Result

Day 1 Interpretations

Positive for COVID-19

Positive for COVID-19

Negative for COVID-19

Positive for COVID-19

Positive for COVID-19

Positive for COVID-19

Negative for COVID-19

Manufacturer REF

Contains sufficient for <n> tests

Consult instructions for use

Distributed by

Temperature limit

Catalogue number

Use-by date

Batch code

Do not reuse

DIST IVD For in vitro diagnostic use

DIST Distributed by

• 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.

Warnings, Precautions, and Safety Information

• Read the Package Insert carefully before performing a test. Failure to follow

directions may produce inaccurate test results.