U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Coronavirus (COVID-19) and Medical Devices
  6. At-Home OTC COVID-19 Diagnostic Tests
  1. Coronavirus (COVID-19) and Medical Devices

At-Home OTC COVID-19 Diagnostic Tests

Español

A woman performing a nose swab on herself as part of a COVID at home test.

On this page:


This page has information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. Diagnostic tests can show if you have an active COVID-19 infection.

These at-home COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations).  This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. Authorized at-home OTC tests are available without a prescription and are typically available online or at local stores.

Testing and other protective steps like wearing a mask and COVID-19 vaccination are essential to stop the spread of COVID-19 infection.

For more information, including answers to frequently asked general questions about at-home COVID-19 diagnostic tests, visit At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.

List of Authorized At-Home OTC COVID-19 Diagnostic Tests 

The table below lists FDA-authorized at-home OTC COVID-19 diagnostic tests, and includes information on expiration dates, who can use the test, and other details that may help you decide what test is right for you.

The table includes links to home use instructions for each test. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs.

In the table below, the "Expiration Date" column lists the shelf-life and where to find the expiration date for that test.  The shelf-life is how long the test should work as expected and is measured from the date the test was manufactured.  The expiration date is set at the end of the shelf-life.  In some cases, the expiration date for a test may be extended. An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized.  For more information about how the expiration date is determined and why it may be extended, see the At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.   

To see if the expiration date for your at-home OTC COVID-19 test has been extended, first find the row in the below table that matches the manufacturer and test name shown on the box label of your test.   

  • If the Expiration Date column says that the shelf-life is "extended," there is a link to "updated expiration dates" where you can find a list of the original expiration dates and the new expiration dates.  Find the original expiration date on the box label of your test and then look for the new expiration date in the "updated expiration dates" table for your test.   
  • If the Expiration Date column does not say the shelf-life is extended, that means the expiration date on the box label of your test is still correct.  The table will say "See box label" instead of having a link to updated expiration dates.  

The FDA will update this table as additional shelf-life extensions are authorized.   

  

Manufacturer and Test Name (Links to Instructions for Use) Who can use this test: Symptoms Who can use this test: Age Other Details Expiration Date

Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Ag Card Home Test

Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Card Home Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Requires supervision of a telehealth proctor and a smartphone or computer
  • Results in 15 minutes

Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Antigen Self Test

Packaging for Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Antigen Self Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Results in 15 minutes

Access Bio, Inc.:
CareStart COVID-19 Antigen Home Test

Packaging for Access Bio, Inc.: CareStart COVID-19 Antigen Home Test

Alternate brand name:

Packaging for On/go COVID-19 Antigen Self-Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Alternate brand name: On/go COVID-19 Antigen Self-Test
  • Results in 10 minutes

ACON Laboratories, Inc:
Flowflex COVID-19 Antigen Home Test

Packaging for ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test

Alternate brand name:

Packaging for On/Go One COVID-19 Antigen Home Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Alternate brand name: On/Go One COVID-19 Antigen Home Test
  • Results in 15 minutes

Becton, Dickinson and Company (BD):
BD Veritor At-Home COVID-19 Test

Packaging for Becton, Dickinson and Company (BD): BD Veritor At-Home COVID-19 Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Requires a smartphone
  • Results in 15 minutes
  • Shelf Life: 6 months 
  • Expiration Date: See box label 

Celltrion USA, Inc.:
Celltrion DiaTrust COVID-19 Ag Home Test

Packaging for Celltrion USA, Inc.: Celltrion DiaTrust COVID-19 Ag Home Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Antigen test
  • Mid-turbinate nasal swab
  • Smartphone optional
  • Results in 15 minutes

Cue Health Inc.:
Cue COVID-19 Test for Home and Over The Counter (OTC) Use

Packaging for Cue Health Inc.: Cue COVID-19 Test for Home and Over The Counter (OTC) Use
  • People with or without symptoms
  • Age 18 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Requires a Cue Cartridge Reader (sold separately)
  • Requires a smartphone
  • Results in 20 minutes
  • Shelf Life: 4 months 
  • Expiration Date: See box label 

Detect, Inc.:
Detect Covid-19 Test

Packaging for Detect, Inc.: Detect Covid-19 Test
  • People suspected of COVID-19
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Requires a Detect Hub (sold separately)
  • Smartphone optional
  • Results in 60 minutes

Ellume Limited:
Ellume COVID-19 Home Test

Packaging for Ellume Limited: Ellume COVID-19 Home Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 16 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Mid-turbinate nasal swab
  • Requires a Smartphone
  • Results in 15 minutes
  • Shelf Life: 12 months
  • Expiration Date: See box label

Genabio Diagnostics Inc.:
Genabio COVID-19 Rapid Self-Test Kit

Packaging for Genabio Diagnostics Inc.: Genabio COVID-19 Rapid Self-Test Kit
  • People with symptoms that began within the last 7 days.
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15-30 minutes
  • Shelf Life: 18 months
  • Expiration Date: See box label

iHealth Labs, Inc.:
iHealth COVID-19 Antigen Rapid Test

Packaging for iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test

Alternate brand name:

Packaging for GoodToKnow COVID-19 Antigen Rapid Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Results in 15 minutes
  • Alternate brand name: GoodToKnow COVID-19 Antigen Rapid Test

InBios International Inc:
SCoV-2 Ag Detect Rapid Self-Test

Packaging for InBios International Inc: SCoV-2 Ag Detect Rapid Self-Test
  • People with symptoms that began within the last 5 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20 minutes

Lucira Health, Inc:
Lucira CHECK-IT COVID-19 Test Kit

Packaging for Lucira Health, Inc: Lucira CHECK-IT COVID-19 Test Kit
  • People with or without symptoms
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Molecular test
  • Nasal swab
  • Smartphone optional
  • Results in 30 minutes

Maxim Biomedical, Inc.:
MaximBio ClearDetect COVID-19 Antigen Home Test

Packaging for Maxim Biomedical, Inc.: MaximBio ClearDetect COVID-19 Antigen Home Test
  • People with symptoms that began within the last 5 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes

OraSure Technologies, Inc.:
InteliSwab COVID-19 Rapid Test

Packaging for OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 18 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Smartphone optional
  • Results in 30 minutes

OSANG LLC:
OHC COVID-19 Antigen Self Test

OHC COVID-19 Antigen Self Test Packaging

Alternate brand name:

Quickfinder Covid-19 Antigen Self Test Packaging
  • People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Alternate brand name: QuickFinder COVID-19 Antigen Self Test
  • Results in 15 minutes

PHASE Scientific International, Ltd.:
INDICAID COVID-19 Rapid Antigen At-Home Test

Packaging for PHASE Scientific International, Ltd.: INDICAID COVID-19 Rapid Antigen At-Home Test
  • People with symptoms that began within the last 6 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20 minutes
  • Shelf Life: 12 months
  • Expiration Date: See box label

Quidel Corporation:
QuickVue At-Home OTC COVID-19 Test

Packaging for Quidel Corporation: QuickVue At-Home OTC COVID-19 Test
  • People with symptoms that began within the last 6 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 10 minutes
  • Shelf Life: 12 months  
  • Expiration Date: See box label 

SD Biosensor, Inc.:
Pilot COVID-19 At-Home Test 1

Packaging for SD Biosensor, Inc.: Pilot COVID-19 At-Home Test
  • People with symptoms that began within the last 6 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 20 minutes

Siemens Healthineers:
CLINITEST Rapid COVID-19 Antigen Self-Test

Packaging for Siemens Healthineer: CLINITEST Rapid COVID-19 Antigen Self-Test
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 11 months  
  • Expiration Date: See box label 

Watmind USA:
Speedy Swab Rapid COVID-19 Antigen Self-Test

Packaging for Watmind USA: Speedy Swab Rapid COVID-19 Antigen Self-Test
  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing)
  • People without symptoms. The test is to be performed two times over three days (serial testing) 
  • Age 14 years and older
  • Age 2 years and older when collected by an adult 
  • Antigen test
  • Nasal swab
  • Results in 15 minutes 
  • Shelf Life: 6 months 
  • Expiration Date: See box label 

Xiamen Boson Biotech Co., Ltd.:
Rapid SARS-CoV-2 Antigen Test Card

Packaging for Xiamen Boson Biotech Co., Ltd.: Rapid SARS-CoV-2 Antigen Test Card
  • People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
  • People without symptoms. The test is to be performed two times over three days (serial testing).
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Antigen test
  • Nasal swab
  • Results in 15 minutes
  • Shelf Life: 6 months
  • Expiration Date: See box label 

Related information: 

  • 1. The Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, is previously known as the COVID-19 At-Home Test. As the manufacturer, SD Biosensor, transitions to this new brand, customers may receive a product with the previously authorized COVID-19 At-Home Test labeling.
Back to Top