At 您所在的位置:网站首页 Eligibility Expiration Date At

At

2024-05-04 20:00| 来源: 网络整理| 查看: 265

Español

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. 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 months

Abbott 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 months

Access 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 months

ACON 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 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

Celltrion 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 months

CorDx, Inc.CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid 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 10 minutes Shelf Life:  9 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: 12 months

Cue 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 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

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 months

InBios 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 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 

Pfizer Inc:Lucira CHECK-IT COVID-19 Test Kit

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 months

Maxim 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 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

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 months

OSANG LLC: QuickFinder COVID-19/Flu Antigen Self Test

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). 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: 12 months

PHASE 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 months

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

Alternative Brand Names:

 

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 months

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

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 months

Siemens 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 months

Watmind 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 months

Xiamen 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: 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

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 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: 18 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

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 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

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). 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: 6 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.  


【本文地址】

公司简介

联系我们

今日新闻

    推荐新闻

    专题文章
      CopyRight 2018-2019 实验室设备网 版权所有