EN

iHealth

COVID-19

Antigen Rapid Test

Instructions for use

Model: ICO-3000/ ICO-3001/ ICO-3002

This product has not been FDA cleared or approved, 

but has been authorized by FDA under an Emergency 

Use Authorization (EUA).

Please read all the information in this instruction for 

use before performing the test. 

For use with anterior nasal swab specimens.

For In Vitro Diagnostic (IVD) Use.

Download App & Open App

Scan the QR code to download the “iHealth 

COVID-19 Antigen Rapid Test” App through your 

smartphone (iOS12.0+, Android 6.0+).

For a full list of compatible smartphones visit: 

https://ihealthlabs.com/pages/support-ICO3000

Register and Log into The App

Watch Video in App

Each step has a corresponding instructional video in the App.

Watch the video and perform the test according to the 

instructions.

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.

Step by Step Instructions

1 Prepare Materials

You may have Test Set 1 OR Test Set 2 in the package. 

Please follow proper steps based on the specific set you 

received.

Test Set 1: Open the package, take out the COVID-19 

Test Card in Pouch, the Tube pre-filled with the 

extraction solution and the Swab. When you are ready 

to proceed with the test, open the foil pouch of the 

COVID-19 Test Card.

1 COVID-19 Test Card 1 Swab

in Pouch

1 Pre Filled Tube

Please go directly to Step 2 Collect Sample. 

Test Set 2: Open the package, take out the COVID-19 

Test Card in Pouch, empty Tube, sealed Solution and 

the Swab. When you are ready to proceed with the 

test, open the foil pouch of the COVID-19 Test Card.

1 Empty Tube and

1 Sealed Solution

1 COVID-19 Test Card 1 Swab

in Pouch

Please look carefully, there are two Edges on the empty

tube. Then squeeze the sealed solution completely 

into the empty tube.

Edge 1

Edge 2

Please confirm the liquid level with or above Edge 2, 

then go to Step 2 Collect Sample. 

Edge 1

Edge 2

Note:

Itis acceptable if the liquid level is above Edge 2. However,

please do not proceed with this test, if the liquid level is 

below Edge 2, as this may result in false or invalid results.

2 Collect Sample

a. Remove the swab from its package, being careful 

not to touch the tip of the swab. Please keep the 

swab package for later use.

b. Gently insert the entire absorbent tip of the swab 

(usually 1/2 to 3/4 of an inch) into your nostril. 

Up to 3/4 

of an inch

Note:

With children, the maximum depth of insertion into the 

nostril may be less than 3/4 of an inch, and you may need 

to have a second person to hold the child’s head while 

swabbing.

c. Firmly and slowly brush against insides of nostril in 

a circular motion against the nasal wall at least 5 

times. Take at least 15 seconds to collect the 

specimen and be sure to collect any nasal drainage 

on the swab. Using the same swab, repeat the same 

sample collection procedure for the other nostril. Be 

sure to brush BOTH nostrils with the SAME SWAB.

Right Nostril Left Nostril

Slowly

Brush

X5

Slowly

Brush

X5

Note:

Failure to swab properly may cause false negative results.

3 Process Sample

a. Tap the tube vertically on the table and twist the 

large orange cap to open the tube.

b. Insert the swab into the tube, touch the bottom of 

the tube with the swab tip, and stir at least 15 times.

X15

Stir

c. Squeeze the sides of the tube to express as much 

liquid as possible from the swab, and then remove 

the swab.

Note:

If you don't squeeze the swab, there may not be 

sufficient sample material to perform the test properly 

(i.e., potentially resulting in a false negative result).

d. Screw back the large orange cap, put the swab 

back into the package. Safely dispose of the swab 

and the package.

4 Add Sample

Twist to open the small white cap of the tube. Add 3 

drops of sample to the Sample Port of the COVID-19 

Test Card. Screw back the small white cap. 

Note: 

A false negative or invalid result may occur if too little 

solution is added to the test card. 

5 Wait 15 Minutes

Start the timer by clicking the “Start Timer” button on 

the App, immediately after adding sample to the 

Sample Port. The result will be ready in 15 minutes.

Note:

Do NOT interpret your test result until after your 15-min 

timer has completed, as the T line may take as long as 

15 minutes to appear.

6 Read Result

Results should not be read after 30 minutes (Result 

shown at 2x magnification).

Note:

A false negative or false positive result may occur if the 

test result is read before 15 minutes or after 30 minutes.

Look carefully Look carefully 

for a C line here. for a T line here.

Note: The T line can be extremely faint. 

7 Test Interpretation

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. 

COVID-19 Positive (+) 

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

the test is positive. 

Below are photos of actual positive tests. Any 

faint visible pink-to-purple test (T) line with the 

control line (C) should be read as positive. 

You do not need to perform repeat testing if you 

have a positive result at any time.

A positive test result means that the virus that causes 

COVID-19 was detected in your sample and it is very 

likely you have COVID-19 and are contagious. Please 

contact your doctor/primary care physician or your 

local health authority immediately and adhere to the 

local guidelines regarding self-isolation. There is a 

very small chance that this test can give a positive 

result that is incorrect (a false positive).

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 healthcare provider.

Invalid

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

Re-test with a new swab and new test kit. An invalid 

result does not indicate if the individual did or did not 

have COVID-19 and should be repeated.

8 Dispose the Test Kit

After test is completed, dispose the kit components 

in trash.

9 Report Test Result

Report the result following the App instructions or 

share your test result with your healthcare provider.
COVID-19 Antigen Rapid Test 

Instructions for Use

Model: ICO-3000/ ICO-3001/ ICO-3002

This product has not been FDA cleared or approved, but 

has been authorized by FDA under an Emergency Use 

Authorization (EUA).

Please read this instruction for use before using the test. 

For use with anterior nasal swab specimens.

For In Vitro Diagnostic (IVD) Use Only.

INTENDED USE

The iHealth COVID-19 Antigen Rapid Test is 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 15 years or older or adult collected 

anterior nasal (nares) swab samples from individuals aged 

2 years or older. This test is authorized for individuals with 

symptoms of COVID-19 within the first seven (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. This test 

can be performed with or without the supervision of a 

telehealth proctor.

The iHealth COVID-19 Antigen Rapid Test does not 

differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of the 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 

patient history and other diagnostic information is 

necessary to determine infection status. Positive results do 

not rule out bacterial infection or co-infection with other 

viruses and the agent detected may not be the definite 

cause of disease. Individuals who test positive with the 

iHealth COVID-19 Antigen Rapid 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 a mask. 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 or public health 

reporting and to receive appropriate medical care or by 

following the mobile application instructions for selfreporting. 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 iHealth COVID-19 Antigen Rapid 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 iHealth COVID-19 Antigen Rapid Test is only for in 

vitro diagnostic use under the Food and Drug 

Administration’s Emergency Use Authorization. This 

product has not been FDA cleared or approved.

FREQUENTLY ASKED QUESTIONS

What are the known and potential risks and benefits 

of the test? 

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-andresponse/mcm-legal-regulatory-and-policyframework/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 iHealth 

COVID-19 Antigen Rapid Test, detect proteins from the 

virus. Due to the lower sensitivity of antigen tests, there is 

a higher chance this test will give you a false negative 

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

How accurate is this Test?

Clinical studies have shown that antigen tests more 

accurately determine whether you are infected with the 

virus that causes COVID-19 when taken multiple times 

across several days. Repeat testing improves test 

accuracy. This serial testing approach is recommended to 

minimize the risk of incorrect results. For more information

on the performance of the test and how the performance 

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

the Healthcare Provider Instructions for Use (IFU), 

available at https://www.ihealthlabs.com.

What if I have a positive test result?

A positive result means that it is very likely you have 

COVID-19 because proteins from the virus that causes 

COVID-19 were found in your sample. You should 

self-isolate from others and contact a healthcare provider 

for medical advice about your positive result.

What if I have a negative test result?

A negative test result indicates that antigens from the 

virus that causes COVID-19 were not detected in your 

sample. However, if you have symptoms of COVID-19, 

and your first test is negative, you should test again in 48 

hours since antigen tests are not as sensitive as molecular 

tests. If you do not have symptoms and received a 

negative result, you should test at least two more times 

with 48 hours in between tests for a total of three tests. If 

you have a negative result, it does not rule out SARS-CoV-2

infection; you may still be infected and you may still infect 

others. It is important that you work with your healthcare 

provider to help you understand the next steps you 

should take.

What does an invalid test result mean?

An invalid result means the test was not able to tell if you 

have COVID-19 or not. If the test is invalid, a new swab 

should be used to collect a new nasal specimen and you 

should test again with a new test.

For other updated FAQ information, please see the 

company website: https://www.ihealthlabs.com

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.

WARNINGS,PRECAUTIONS AND SAFETY 

INFORMATION

• Read all instructions carefully before performing the 

test. Failure to follow the instructions may result in 

inaccurate test results. 

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

approved, but has been authorized by FDA under an 

Emergency Use Authorization. This product has been 

authorized only for the detection of proteins from 

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

emergency use of this product is only authorized for the 

duration of the declaration that circumstances exist 

justifying the authorization of emergency use of in vitro 

diagnostics for detection and/or diagnosis of COVID-19 

under Section 564(b)(1) of the Federal Food, Drug, and 

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

declaration is terminated or authorization is revoked 

sooner.

• Serial testing should be performed in individuals with 

negative results at least twice over three days (with 48 

hours between tests) for symptomatic individuals and 

three times over five days (with at least 48 hours 

between tests) for asymptomatic individuals. You may 

need to purchase additional tests to perform this 

serial (repeat) testing. 

• An anterior nasal swab sample can be self-collected by 

an individual age 15 years and older. Children age 2 to 

14 years should be tested by an adult. 

• 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.

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

• Do not use on anyone who is prone to nosebleeds or 

has had facial or head injury/surgery in the last 6 

months.

• 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.

• Insert the swab into the tube right after taking the 

sample.

• Test samples immediately after collection, but no more 

than 4 hours after specimen collection before 

placement into extraction buffer or up to 2 hours after 

placement into extraction buffer, if kept at room 

temperature. 

• Once opened, the test card should be used within 60 

minutes.

• 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. 

• Keep testing kit and kit components away from 

children and pets before and after use. Avoid contact 

with your eyes 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 Name Harms (GHS Code) for Concentration

each ingredient 

Triton X-100 / Harmful if swallowed (H302) 0.1%

9002-93-1 Cause skin irritation (H315)

Causes serious eye damage 

(H318) 

ProClin® 300 Harmful if swallowed (H302) 

Harmful if inhaled (H332) 

Causes severe skin burns 

0.05%

and eye damage (H314) 

May cause an allergic skin 

reaction (H317)

• For more information on EUAs please visit: 

https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policyframework/emergency-use-authorization 

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

please visit:www.cdc.gov/COVID19. 

• This test has not been validated for use with a video 

camera and faint bands may not be visible to a 

telehealth proctor due to differences between cameras.

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 May, 2021 and October, 2021. The 

clinical performance has not been established for all 

circulating variants but is anticipated to be reflective of 

the prevalent variants in circulation at the time and 

location of the clinical evaluation. Performance at the 

time of testing may vary depending on the variants 

circulating, including newly emerging strains of 

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

• All COVID-19 antigen test negative results are 

presumptive and confirmation with a molecular assay 

may be necessary. If you continue to have symptoms of 

COVID-19, and both your first and second tests are 

negative, you may not have COVID-19, however you 

should follow-up with a healthcare provider.

• If the test is positive, then proteins from the virus that 

causes COVID-19 have been found in the sample and 

you likely have COVID-19. 

• This test is read visually and has not been validated for 

use by those with impaired vision or color-impaired 

vision.

• Incorrect test results may occur if a specimen is 

incorrectly collected or handled. 

STORAGE AND OPERATION CONDITIONS

Store iHealth COVID-19 Antigen Rapid Test in a dry place 

between 36-86 °F (2-30 °C). Ensure all test components 

are at room temperature 65-86 °F (18-30 °C) before use. 

It is stable before the expiration date marked on the 

packaging.

For information about current expiration dates for 

at-home OTC COVID-19 diagnostic tests, visit 

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

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705 

 Rev.08/2023
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

Instrucciones de uso en español ubicadas 

dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of 

SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

This test can be performed with or without the supervision of a telehealth proctor, to access the 

telehealth proctor services, please visit: iHealthLabs.com/air

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

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

by FDA under an EUA. This product has been authorized only for the detection of 

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

The emergency use of this product is only authorized for the duration of the declaration 

that circumstances exist justifying the authorization of emergency use of in vitro 

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

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

is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please refer to:

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

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

Manufactured for iHealth Labs, Inc. 

880

W Maude Ave, Sunnyvale, CA94085 USA

www.ihealthlabs.com 1-855-816-7705

Contents

1 × COVID-19 Test Card; 1 × Swab; 1 × Pre Filled Tube

COVID-19 Test Card Swab

Pre Filled Tube Empty Tube & Sealed Solution

Components

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

iHealth Manufacturing Inc.

15715 Arrow Hwy, Irwindale, CA 91706 

8 56362 00000 0
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” App to 

quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

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The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

Components

Pre Filled Tube Empty Tube & Sealed Solution COVID-19 Test Card Swab

Contents

2 × COVID-19 Test Cards; 2 × Swabs; 2 × Pre Filled Tubes

Materials required but are not provided in the kit: 

 Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

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2022-05-04

Manufactured for iHealth Labs, Inc.

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705

iHealth Manufacturing Inc.

15715 Arrow Hwy, Irwindale, CA 91706 
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

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Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

cy Use 

Components

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FDA

For Emerge

Authorization(EUA) only

Contents

4 × COVID-19 Test Cards; 4 × Swabs; 4 × Pre Filled Tubes

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

20856362005894

211CO21105

2022-05-04

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705 

iHealth Manufacturing Inc.

15715 Arrow Hwy, Irwindale, CA 91706 
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

please visit: iHealthLabs

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Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Components

Contents

5 × COVID-19 Test Cards; 5 × Swabs; 5 × Pre Filled Tubes

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

20856362005894

211CO21105

2022-05-04

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705 

iHealth Manufacturing Inc.

15715 Arrow Hwy, Irwindale, CA 91706 
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

please visit: iHealthLabs

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Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Components

Contents

6 × COVID-19 Test Cards; 6 × Swabs; 6 × Pre Filled Tubes

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

20856362005894

211CO21105

2022-05-04

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085, USA

www.ihealthlabs.com 1-855-816-7705 

iHealth Manufacturing Inc.

15715 Arrow Hwy, Irwindale, CA 91706 
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Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

This test can be performed with or without the supervision of a 

telehealth proctor, to access the telehealth proctor services, please 

visit: iHealthLabs.com/air

Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of 

SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

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

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

by FDA under an EUA. This product has been authorized only for the detection of 

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

The emergency use of this product is only authorized for the duration of the declaration 

that circumstances exist justifying the authorization of emergency use of in vitro 

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

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

terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please refer to:

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Components

Contents

40 × COVID-19 Test Cards; 40 × Swabs; 40 × Pre Filled Tubes

imerT oid 6.0+) ndr tphone (iOS12.0+, A Smar

it: vided in the k oe not pr ed but ar equirials rertaM

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085, USA

www.ihealthlabs.com 1-855-816-7705

20856362005894

211CO21105

2022-05-04

iHealth Manufacturing Inc.

15715 Arrow Hwy, Irwindale, CA 91706 
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

Instrucciones de uso en español ubicadas 

dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of 

SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

This test can be performed with or without the supervision of a telehealth proctor, to access the 

telehealth proctor services, please visit: iHealthLabs.com/air This test does NOT determine if you had COVID-19 in the past or if you have immunity.

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

by FDA under an EUA. This product has been authorized only for the detection of 

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

The emergency use of this product is only authorized for the duration of the declaration 

that circumstances exist justifying the authorization of emergency use of in vitro 

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

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

is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please refer to:

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

COVID-19 Test Card Swab

Pre Filled Tube Empty Tube & Sealed Solution

Components

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 8 56362 00000 

0

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705

Contents

1 × COVID-19 Test Card; 1 × Swab; 1 × Pre Filled Tube

Made in China
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” App to 

quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

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Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

Components

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Contents

2 × COVID-19 Test Cards; 2 × Swabs; 2 × Pre Filled Tubes

Materials required but are not provided in the kit: 

 Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

20856362005894

211CO21105

2022-05-04

Manufactured for iHealth Labs, Inc.

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705

Made in China
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

please visit: iHealthLabs

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elehealth pr

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vision of a 

iH

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Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Components

ncy Use 

FDA

For Emerge

Authorization(EUA) only

Contents

4 × COVID-19 Test Cards; 4 × Swabs; 4 × Pre Filled Tubes

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

894

5

20856362005

211CO2110

2022-05-04

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA 

www.ihealthlabs.com 1-855-816-7705 

Made in China
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

please visit: iHealthLabs

elehealth pr t

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elehealth pr

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oct

wnload the 

or ser

“

vision of a 

iH

vices, 

ealth 

. tphone

Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Components

Contents

5 × COVID-19 Test Cards; 5 × Swabs; 5 × Pre Filled Tubes

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705 

894

5

20856362005

211CO2110

2022-05-04

Made in China
COVID-19

Antigen Rapid Test

FDA

For Emergency Use 

Authorization(EUA) only

If you want to use the telehealth testing, please

do not open the kit package until instructed to do so.

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” 

App to quickly start the test.

For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000

please visit: iHealthLabs

elehealth pr t

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elehealth pr

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oct

wnload the 

or ser

“

vision of a 

iH

vices, 

ealth 

. tphone

Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative 

detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal 

(nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

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

have immunity.

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

authorized by FDA under an EUA. This product has been authorized only for the 

detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the 

declaration that circumstances exist justifying the authorization of emergency use 

of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 

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

unless the declaration is terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please 

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Components

Contents

6 × COVID-19 Test Cards; 6 × Swabs; 6 × Pre Filled Tubes

Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705 

20856362005894

211CO21105

2022-05-04

Made in China
) onlyAtion(EU uthorizaA

se y Ugenc or EmerF

DAF

.o do soed ttuctil instr age un it pack en the k do not op

, please esting elehealth t o use the t t tanou wf yI

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.estt the tly star o quickpp tA

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tigenn-19 AVIDOealth CiH“ wnload the o dode to an the QR c cS

Scan the QR code to download the “iHealth COVID-19 Antigen 

Rapid Test” App on smartphone. 

This test can be performed with or without the supervision of a 

telehealth proctor, to access the telehealth proctor services, please 

visit: iHealthLabs.com/air

Instrucciones de uso en español 

ubicadas dentro de la App.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of 

SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.

For in vitro diagnostic use.

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.

DO USE DO NOT USE

As an aid in the diagnosis On anyone under 2 years of age

of COVID-19

If you are prone to nose bleeds

If you are concerned that 

you have been exposed If you have had a facial or head 

to COVID-19 injury/surgery in the last 6 months

Use within 1 hour after opening the foil pouch of COVID-19 Test Card.

Avoid contact of the extraction solution with your skin, eyes, nose or mouth.

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

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

by FDA under an EUA. This product has been authorized only for the detection of 

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

The emergency use of this product is only authorized for the duration of the declaration 

that circumstances exist justifying the authorization of emergency use of in vitro 

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

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

terminated or authorization is revoked sooner.

For more information on expiration dating for COVID-19 antigen tests, please refer to:

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

COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution

Components

Contents

40 × COVID-19 Test Cards; 40 × Swabs; 40 × Pre Filled Tubes

imerT oid 6.0+) ndr tphone (iOS12.0+, A Smar

it: vided in the k oe not pr ed but ar equirials rertaM

Model: ICO-3000 

 ICO-3001 

 ICO-3002 

Manufactured for iHealth Labs, Inc. 

880 W Maude Ave, Sunnyvale, CA 94085 USA

www.ihealthlabs.com 1-855-816-7705

20856362005894

211CO21105

2022-05-04

Made in China