FDA Lists Expiration Dates for At-Home COVID-19 Tests
Summary
The FDA has updated its list of authorized at-home COVID-19 diagnostic tests, including information on extended expiration dates. This guidance helps consumers and healthcare providers identify currently valid tests.
What changed
The FDA has updated its guidance document to include a regularly updated list of authorized at-home over-the-counter (OTC) COVID-19 diagnostic tests. The primary focus of this update is to provide information on expiration dates, including any extensions granted by the FDA. This aims to ensure that individuals have access to accurate and reliable testing options.
While this document is primarily informational, regulated entities such as manufacturers should ensure their product listings and communications align with the FDA's updated information. Consumers are advised to check the FDA's website for the most current expiration dates to ensure they are using valid tests. No specific compliance actions are mandated for regulated entities beyond ensuring accurate representation of product shelf-life as per FDA authorization.
What to do next
- Review the FDA's updated list of authorized at-home COVID-19 diagnostic tests.
- Verify expiration dates for any at-home COVID-19 tests currently in use or inventory.
- Refer to the FDA's guidance for information on test usage and reporting of results.
Source document (simplified)
On this page:
- General Information About At-Home OTC COVID-19 Diagnostic Tests
- Authorized At-Home OTC COVID-19 Diagnostic Tests and Expiration Dates
- Related Information
General Information About At-Home OTC COVID-19 Diagnostic Tests
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. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can send your test result to MakeMyTestCount.org or use an app or other digital option for self-reporting that may be included with your test. 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, 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. You can also review the At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions.
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
| 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 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 months |
| Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Antigen Self 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 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 months |
| Access Bio, Inc.:
CareStart COVID-19 Antigen Home Test
| 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
- Smartphone optional
- Alternate brand name: On/go COVID-19 Antigen Self-Test
- Results in 10 minutes
- Shelf Life: 21 months |
| ACON Laboratories, Inc:
Flowflex COVID-19 Antigen Home Test
| 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
- Smartphone optional
- Alternate brand name: On/Go One COVID-19 Antigen Home Test
- Results in 15 minutes
- Shelf Life: 24 months |
| Aptitude Medical Systems Inc.:
Metrix COVID-19 Test
| 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
- Saliva
- Requires a Metrix Reader (sold separately)
- Smartphone optional
- Results in 30 minutes
- Shelf Life: 18 Months |
| CorDx, Inc.
CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid 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). | - 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: 24 months |
| CTK Biotech, Inc.:
ImmuView 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: 20 months |
| Ellume 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 months |
| Genabio 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 months |
| iHealth Labs, Inc.:
iHealth COVID-19 Antigen Rapid 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 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 months |
| InBios International Inc:
SCoV-2 Ag Detect Rapid 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: 13 months |
| 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 months |
| Maxim Biomedical, Inc.:
MaximBio ClearDetect 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 minutes
- Shelf Life: 24 months |
| Mologic, 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 months |
| OraSure 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 months |
| OSANG LLC:
OHC 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
- Alternate brand name: QuickFinder COVID-19 Antigen Self Test
- Results in 15 minutes
- Shelf Life: 24 months |
| PHASE Scientific International, Ltd.:
INDICAID COVID-19 Rapid 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 20 minutes
- Shelf Life: 15 months |
| Quidel Corporation:
QuickVue At-Home OTC COVID-19 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
- 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 months |
| Watmind USA: Speedy Swab Rapid COVID-19 + Flu A&B Antigen 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). | - 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: 18 months |
| SD Biosensor, Inc.:
Pilot COVID-19 At-Home Test 1
FDA Safety Communication - Recall of Certain Lots | 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 20 minutes
- Telehealth Proctor Supervised (optional)
- Shelf Life: 16 months |
| Siemens Healthineers:
CLINITEST Rapid COVID-19 Antigen Self-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 minutes
- Smartphone/Web access (optional)
- Shelf Life: 24 months |
| Watmind USA:
Speedy Swab Rapid COVID-19 Antigen Self-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: 21 months |
| Xiamen Boson Biotech Co., Ltd.:
Rapid SARS-CoV-2 Antigen Test Card
| 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: 18 months |
| SEKISUI Diagnostics, LLC.:
OSOM 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: 11 months |
| Beijing Hotgen Biotech Co., Ltd.:
Hotgen 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: 10 months |
| CorDX, 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 months |
| Azure 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 months |
| Oceanit Foundry LLC:
ASSURE-100 Rapid COVID-19
| 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 months |
| Advin Biotech Inc.:
Advin COVID-19 Antigen Test @Home
| 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: 24 months |
| GenBody 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 months |
| Azure 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 months |
| Pfizer Inc.:
Lucira by Pfizer COVID-19 & Flu Home 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: 18 months |
| Princeton 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 months |
| Nano-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 months |
| BioTeke 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 months |
| 3EO Health, Inc.:
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 |
| SEKISUI Diagnostics, LLC:
OSOM Flu SARS-CoV-2 Combo Home Test
| Extended Expiration Date | - People with symptoms that began within the last 4 days. 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 10-30 minutes
- Shelf Life: 20 months |
| Wondfo USA Co., Ltd.
WELLlife COVID-19 / Influenza A&B 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). | - 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: 15 months |
| iHealth Labs, Inc.:
iHealth COVID-19/Flu A&B Rapid Test
| Extended Expiration Date | - People with symptoms that began within the last 4 days. 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: 20 months |
| ACON Laboratories, Inc.:
Flowflex Plus COVID-19 and Flu A/B 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). | - 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 months |
| Aptitude Medical Systems Inc.:
Metrix COVID/Flu Test, Matrix Reader
| 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
- Saliva
- Requires a Metrix Reader Gen 2 (sold separately)
- Smartphone optional
- Results in 20 minutes
- Shelf Life: 12 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
- Video: How to Interpret Self-Test Results | 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.
- 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.
- ## Content current as of:
02/23/2026
Regulated Product(s)
- Medical Devices
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA CDRH Medical Devices News publishes new changes.