An official website of the United States government Here’s how you know
In this section: Coronavirus (COVID-19) and Medical Devices
  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

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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Shelf Life: 12 months 
  • Expiration Date: See box label 
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
  • 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
  • People with or without symptoms
  • 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 
iHealth Labs, Inc.:
iHealth 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
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
  • 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
  • Shelf Life: 6 months 
  • Expiration Date: See box label 
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
  • Shelf Life: 6 months  
  • Expiration Date: See box label 
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
  • Shelf Life: 9 months  
  • Expiration Date: See box label 
OSANG LLC:
OHC COVID-19 Antigen Self Test
  • 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
  • Results in 15 minutes
  • Shelf Life: 8 months 
  • Expiration Date: See box label 
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
  • 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
  • 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: 6 months  
  • Expiration Date: See box label 
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 
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: 

Back to Top