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 In this section:

                Coronavirus (COVID-19) and Medical Devices

Coronavirus (COVID-19) and Medical Devices

                        At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19 Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)
          Coronavirus (COVID-19) and Medical Devices
          At-Home OTC COVID-19 Diagnostic TestsCoronavirus (COVID-19) and Medical Devices At-Home OTC COVID-19 Diagnostic Tests
  
  	
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General Information About At-Home OTC COVID-19 Diagnostic Tests
	Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates
	Related InformationGeneral Information About At-Home OTC COVID-19 Diagnostic Tests

A woman performing a nose swab on herself as part of a COVID at home test.
At-home over-the-counter (OTC) COVID-19 diagnostic tests can show if you have an active COVID-19 infection.

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

With most at-home OTC COVID-19 diagnostic tests, you should repeat testing following a negative result, whether you have symptoms or not, to reduce your risk of a false negative test result. For additional information on reading and understanding your test results, see **Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results**.

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.

Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates

The table below is updated regularly and lists FDA-authorized at-home OTC COVID-19 diagnostic tests, including information on expiration dates, who can use the test, links to home use instructions for each test, and other details that may help you decide what test is right for you. For additional information about each Emergency Use Authorization (EUA), see **In Vitro Diagnostics EUAs: Tables of IVD EUAs**.

In the table below, the "Expiration Date" column lists where to find the expiration date for that test, and the "Other Details" column lists the shelf-life for the 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 and is the date through which the test is expected to perform as accurately as when manufactured. 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 has been extended, then the Expiration Date column states "**Extended Expiration Date**" and links to a document that lists the lot numbers, original expiration dates, and the extended expiration dates. If your lot number and/or original expiration date do not appear, or if the Expiration Date column states “Expiration Date: See box label,” do not use the test beyond the original expiration date on your test.

Search the table below by manufacturer, test name, or other details shown in the table to find more information on the test, including if the expiration date has been extended.

To see complete information on smaller screens, select the blue plus (+) button beside the test name.

**Manufacturer and Test Name (Links to Instructions for Use)**
			Expiration Date
			**Who can use this test: Symptoms**
			**Who can use this test: Age**
			**Other Details**Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Ag Card Home Test
			Extended Expiration Date
			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 three times over five 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
				Shelf Life: 22 monthsAbbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Antigen Self Test
			Extended Expiration Date
			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 three times over five days (serial testing).
			Age 15 years and older
				Age 2 years and older when collected by an adult
			Antigen test
				Nasal swab
				Results in 15 minutes
				Shelf Life: 22 monthsAccess Bio, Inc.:CareStart COVID-19 Antigen Home Test
			

			Alternate brand name:
			Extended Expiration Date
			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
				Shelf Life: 21 monthsACON Laboratories, Inc:Flowflex COVID-19 Antigen Home Test
			

			Alternate brand name:
			Extended Expiration Date
			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
				Shelf Life: 24 monthsAptitude Medical Systems Inc.:Metrix COVID-19 Test
			Expiration Date: See box label
			People with or without symptoms
			Age 14 years and older
				Age 2 years and older when collected by an adult
			Molecular test
				Nasal swab
				Saliva
				Requires a Metrix Reader (sold separately)
				Smartphone optional
				Results in 30 minutes
				Shelf Life: 12 MonthsCelltrion USA, Inc.:Celltrion DiaTrust COVID-19 Ag Home Test
			Extended Expiration Date
			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 three times over five days (serial testing).
			Age 14 years and older
			Antigen test
				Mid-turbinate nasal swab
				Smartphone optional
				Results in 15 minutes
				Shelf Life: 24 monthsCTK Biotech, Inc.: ImmuView COVID-19 Antigen Home Test

			ImmuView COVID-19 Antigen Home Test - Instructions for Use (Home Test)
			Expiration Date: See box label
			People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five 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: 12 monthsCue Health Inc.:Cue COVID-19 Test for Home and Over The Counter (OTC) Use
			Expiration Date: See box label
			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 monthsEllume Limited:Ellume COVID-19 Home Test
			Expiration Date: See box label
			People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five 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 monthsGenabio Diagnostics Inc.:Genabio COVID-19 Rapid Self-Test Kit
			Expiration Date: See box label
			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 monthsiHealth Labs, Inc.:iHealth COVID-19 Antigen Rapid Test
			

			Alternate brand name:
			Extended Expiration Date
			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 three times over five 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
				Alternate brand name: GoToKnow COVID-19 Antigen Rapid Test
				Shelf Life: 15 monthsInBios International Inc:SCoV-2 Ag Detect Rapid Self-Test
			Extended Expiration Date
			People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five 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: 13 monthsImmunostics Inc.:Swab-N-Go Home Test COVID-19 Ag

			Box Label:  Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag
			Expiration Date: See box label
			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 three times over five 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: 20 monthsPfizer Inc:Lucira CHECK-IT COVID-19 Test Kit

			Pfizer Check Box Label
			Extended Expiration Date
			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: 18 monthsMaxim Biomedical, Inc.:MaximBio ClearDetect COVID-19 Antigen Home Test
			Extended Expiration Date
			People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five 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: 24 monthsMologic, Inc.:COVI-Go SARS-CoV-2 Ag Self-Test
			Expiration Date: See box label
			People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five 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 monthsOraSure Technologies, Inc.:InteliSwab COVID-19 Rapid Test
			Extended Expiration Date
			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 three times over five 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: 24 monthsOSANG LLC:OHC COVID-19 Antigen Self Test
			

			Alternate brand name:
			Extended Expiration Date
			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 three times over five 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
				Shelf Life: 24 monthsPHASE Scientific International, Ltd.:INDICAID COVID-19 Rapid Antigen At-Home Test
			Extended Expiration Date
			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 three times over five 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: 15 monthsQuidel Corporation:QuickVue At-Home OTC COVID-19 Test
			

			Alternative Brand Names:

			CVS Health At Home COVID-19 Test Kit


			Walgreens At-Home COVID-19 Test Kit
			Extended Expiration Date
			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 three times over five days (serial testing).
			Age 14 years and older
				Age 2 years and older when collected by an adult
			Antigen test
				Nasal swab
				Alternative Brand Names: CVS Health At Home COVID-19 Test Kit and Walgreens At-Home COVID-19 Test Ket
				Results in 10 minutes
				Shelf Life: 16 monthsSD Biosensor, Inc.:Pilot COVID-19 At-Home Test1
			

			FDA Safety Communication - Recall of Certain Lots
			Extended Expiration Date
			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 three times over five 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
				Telehealth Proctor Supervised (optional)
				Shelf Life: 16 monthsSiemens Healthineers:CLINITEST Rapid COVID-19 Antigen Self-Test
			Extended Expiration Date
			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 three times over five 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
				Smartphone/Web access (optional)
				Shelf Life: 24 monthsWatmind USA:Speedy Swab Rapid COVID-19 Antigen Self-Test
			Extended Expiration Date
			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 three times over five 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: 21 monthsXiamen Boson Biotech Co., Ltd.:Rapid SARS-CoV-2 Antigen Test Card
			Extended Expiration Date
			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 three times over five 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: 14 monthsSEKISUI Diagnostics, LLC.:OSOM COVID-19 Antigen Home Test

			OSOM COVID-19 Antigen Home Test - box label
			Expiration Date: See box label
			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 three times over five 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: 11 monthsBeijing Hotgen Biotech Co., Ltd.:Hotgen COVID-19 Antigen Home Test
			Extended Expiration Date
			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 three times over five 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: 10 monthsCorDX, Inc.:CorDx COVID-19 Ag Test
			Expiration Date: See box label
			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 three times over five days (serial testing).
			Age 14 years and older
				Age 2 years and older when collected by an adult
			Antigen test
				Nasal swab
				Results in 10-30 minutes
				Shelf Life: 15 monthsAzure Biotech Inc.:Fastep COVID-19 Antigen Home Test
			Expiration Date: See box label
			People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five 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: 24 monthsOceanit Foundry LLC:ASSURE-100 Rapid COVID-19

			Photo of Oceanit Assure Covid Test Box
			Expiration Date: See box label
			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 three times over five days (serial testing).
			Age 14 years and older
				Age 2 years and older when collected by an adult
			Antigen test
				Nasal swab
				Results in 20-30 minutes
				Shelf Life: 12 monthsAdvin Biotech Inc.:Advin COVID-19 Antigen Test @Home

			Photo of AdvinBio_Covid16 Test box
			Extended Expiration Date
			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 three times over five 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 monthsGenBody Inc.:GenBody COVID-19 Ag Home Test
			Expiration Date: See box label
			People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five days (serial testing).
			Age 14 years and older
				Age 2 years and older when collected by an adult
			Antigen test
				Nasal swab
				Results in 15-20 minutes
				Shelf Life: 24 monthsAzure Biotech, Inc.:Azure FaStep® COVID-19 Antigen Pen Home Test
			Expiration Date: See box label
			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 three times over five 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: 21 monthsPfizer Inc.:Lucira by Pfizer COVID-19 & Flu Home Test
			Extended Expiration Date
			People with symptoms
			Age 14 years and older
				Age 2 years and older when collected by an adult
			Molecular test
				Nasal swab
				Results in 30 minutes
				Shelf Life: 18 monthsPrinceton BioMeditech Corp:Status COVID-19 Antigen Rapid Test for Home Use
			Expiration Date: See box label
			People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
				People without symptoms. The test is to be performed three times over five 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: 24 monthsNano-Ditech Corporation:Nano-Check COVID-19 Antigen At-Home Test
			Expiration Date: See box label
			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 three times over five 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 monthsBioTeke USA, LLC:Bio-Self COVID-19 Antigen Home Test
			Expiration Date: See box label
			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 three times over five 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: 12 months3EO Health, Inc.:3EO Health COVID-19 Test

			Packaging for 3EO Health COVID-19 Test
			Expiration Date: See box label
			People with symptoms.
			Age 14 years and older
				Age 2 years and older when collected by an adult
			Molecular test
				Nasal swab
				Results in 30 minutes
				Shelf Life: 4 months

Related Information:

COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
	Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results
	At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
	COVID-19 Test Basics: Includes details on COVID-19 tests, types of samples, and other information.
	At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication
	Counterfeit At-Home OTC COVID-19 Diagnostic Tests
	Find COVID-19 Tests at COVID.gov/tests
	Video: How to Interpret Self-Test Results | CDC
	COVID-19 Testing: What You Need to Know | CDC
	COVID-19 Self-Testing At-Home or Anywhere | CDC
	What to Do If You Were Exposed to COVID-19 | CDC
	Isolation and Precautions for People with COVID-19 | CDC
	Video: What Is an EUA? Describes how the FDA can issue an emergency use authorization (EUA) to provide more timely access to diagnostic tests that may help during the public health emergency when there is no adequate, approved, and available alternative.


1The 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.

                                                                                  Content current as of:
      01/16/2024
              
              
Regulated Product(s)
		 Medical DevicesCoronavirus (COVID-19) and Medical Devices

          
                        At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19
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