list of fda approved covid tests

On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The FDA communicated recommendations consistent with this revision in the August 11, 2022, Safety Communication: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative. . Depending on the intended use, COVID-19 diagnostic tests can be performed at a laboratory, a standalone testing site, a doctors office or health clinic, or at home. An antigen test, frequently used for rapid testing, detects viral proteins found in SARS-CoV-2. The FDA said it has authorized over 400 COVID-19 tests and collection kits - 235 molecular, 88 antibody, and 34 antigen tests -- to help ensure the public has access to a wide variety of. BD Veritor At-Home COVID-19 Test W - Patient care settings operating under a CLIA Certificate of Waiver. This article's lead section may be too long for the length of the article. However, antibody test results are not reported on the state's dashboard anyway. As the number of people wanting to get tested for COVID-19 ahead of the holidays has spiked in recent days, many people have gone looking for an alternative that doesn't involve sitting in a line of cars for hours at a time. This page also provides answers to FAQ's that pertain to testing types and supplies. The .gov means its official.Federal government websites often end in .gov or .mil. Any test developer requesting an EUA that intends to leverage data from another developer's EUA-authorized device must obtain a right of reference to leverage the performance data for that EUA-authorized device. Lab is running FDA EUA molecular or antigen diagnostic tests. Diagnostic tests can show if you have an active COVID-19 infection. , Multiple Targets, RT-PCR, Microarray Hybridization, Home Collection, Multiple Targets, RT, Nested multiplex PCR, Multi-analyte, Multiple Targets, University of California, Los Angeles (UCLA), RT-PCR and electrochemical detection, Multi-analyte, Single Target, RT, qSTAR amplification, Home Collection, Screening, Pooling, Single Target, Real-Time RT-PCR, Pooling, Screening, Pooled Serial Screening - Swab, Multiple Targets, RT-PCR, chip array and MALDI-TOF Mass Spec, Multiple Targets, Prescription Home Testing, Multiple Targets, Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory, Real-time RT-PCR, Collection Kit, Saliva, Multiple Targets, Stanford Health Care Clinical Virology Laboratory, Laboratory Corporation of America (LabCorp), Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening, Multiple Targets, RCA Laboratory Services LLC dba GENETWORx, ResearchDx, Inc., DBA Pacific Diagnostics, Real-time TMA, chemiluminescent, Multi-analyte, Multiple Targets, Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA), Single Target, Hospital of the University of Pennsylvania, INNO Diagnostics Reference Laboratory, Ponce Medical School, Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Multiple Targets, Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening, Single Target, University of Illinois Office of the Vice President for Economic Development and Innovation, Real-time RT-PCR, Saliva, Serial Screening, Home Collection, Pooling, Multiple Targets, RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Screening, Single Target, Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard, Real-time RT-PCR, Home Collection, Pooled Serial Screening - Swab, Multiple Targets, Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening, Multiple Targets, STS Lab Holdco (a subsidiary of Amazon.com Services LLC), Real-time RT-PCR, Home Collection, Pooling, Screening, Single Target, University of Louisville Infectious Diseases Laboratory, RT, LAMP, Over the Counter (OTC) Home Testing, Screening, Multiple Targets, Real-time RT-PCR, Screening, Pooled Serial Screening - Swab, Multiple Targets, Real-Time and End-Point RT-PCR, Multiple Targets, Synergy Diagnostic Laboratory, Inc., DBA SynergyDx, Southern California Permanente Medical Group, Real-Time RT-PCR, Saliva, Home Collection, Multiple Targets, RT-PCR, DNA Microarray Hybridization, Multiple Targets, Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening, Multiple Targets, Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia, Home Collection, Multiple Targets, Harvard University Clinical Laboratory (HUCL), Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening, Multiple Targets, Real-time RT-PCR, Multi-analyte, Home Collection, Single Target, Real-time RT-PCR, Screening, Home Collection, Multiple Targets, Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.), Real-time RT-PCR, Home Collection, Screening, Single Target, Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Direct to Consumer (DTC), Home Collection Kit, Screening, Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Multiple Targets, Screening, Real-time RT-PCR, Home Collection, Multi-analyte, Multiple Targets, RT-LAMP, Serial Screening, Multiple Targets, Real-time RT-PCR, Quantitative, Multiple Targets, RT, Non-isothermal Nucleic Acid Amplification qSTAR, Multi-analyte, Single Target, ADL Diagnostics, Inc., dba Anavasi Diagnostics, The HFI Laboratory at Boston University (dba the BU Clinical Testing Laboratory), RT, LAMP, Over the Counter (OTC) Home Testing, Multi-analyte, Multiple Targets, Clinical Enterprise SARS-SoV-2-RT-PCR Assay, Helix Diagnostics SARS nCoV-2019 Multiplexed Assay, Rize Laboratory SARS nCoV-2019 Multiplexed Assay, Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay, Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia, Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory, Southwest Regional PCR Laboratory LLC. They detect current infection and are sometimes also called "home tests," "at-home tests," or "over-the-counter (OTC) tests.". 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. To increase the accuracy of an at-home COVID-19 antigen diagnostic test, it is important to perform repeat testing, after 48 hours, following a negative test result, whether you have symptoms or not, to reduce your risk of a false negative test result. There are several types of SARS-CoV-2 and COVID-19 related IVDs: The web pages below include tables of SARS-CoV-2 and COVID-19 related IVDs with emergency use authorizations (EUAs). The latest Arizona headlines, breaking news, in-depth investigations, politics, and local community stories that matter to you. Another way to find the updated list of expiration dates is on the FDA's website. More research is needed to determine what, if anything, antibody tests can tell us about a persons immunity. Please read the layout guide and lead section guidelines to ensure the section will still be inclusive of all essential details. For three weeks . The FDA will update this table as additional shelf-life extensions are authorized. Coronavirus (COVID-19) and Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) and Medical Devices, Counterfeit At-Home OTC COVID-19 Diagnostic Tests, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Blood Specimen Collection Tube Shortage: Frequently Asked Questions, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDAs Response, Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19, Medical Device Supply Chain Notifications During the COVID-19 Pandemic, Medical Device Shortages During the COVID-19 Public Health Emergency, Supplies of Medical Devices for COVID-19: Frequently Asked Questions, Medical Device Types to Help Determine Section 506J Notification Obligations, Non-contact Temperature Assessment Devices During the COVID-19 Pandemic, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents, Contacts for Medical Devices During the COVID-19 Pandemic, General Information About At-Home OTC COVID-19 Diagnostic Tests, List of Authorized At-Home OTC COVID-19 Diagnostic Tests, In Vitro Diagnostics EUAs: Tables of IVD EUAs, See link for list of updated expiration dates, Cue COVID-19 Test for Home and Over The Counter (OTC) Use, MaximBio ClearDetect COVID-19 Antigen Home Test, link for list of updated expiration dates, INDICAID COVID-19 Rapid Antigen At-Home Test, CLINITEST Rapid COVID-19 Antigen Self-Test, Speedy Swab Rapid COVID-19 Antigen Self-Test, Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication, 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. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. Our Spectrum News app is the most convenient way to get the stories that matter to you. The Centers for Disease Control and Prevention (CDC) has granted a right of reference to the performance data contained in CDC's EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device. Walmart. This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. As such, KOMU 8 is the only major network affiliate in the United States that acts as a university-owned commercial television station utilizing its newsroom as a working lab for students. For best results, the company says to wait at least 24 hours (but no more than 48 hours) in between tests. The Food and Drug Administration prohibited 65 manufacturers from selling masks for medical use. People with symptoms that began within the last 4 days. Since the start of the pandemic, we authorized over 400 tests and collection kits, including: For more information, please visit fda.gov/medical-devices. (File Photo). In 1947, Salk accepted a professorship at the University of Pittsburgh School of . Below are the lists of RT-PCR, antigen, and antibody rapid test kit brands that the Philippine Food and Drug Administration (FDA) has approved for commercial use, based on the performance. Diagnostic tests can show if you currently are infected with SARS-CoV-2, the virus that causes COVID-19. Everlywell was one of the first brands to release its at-home coronavirus test kit. In certain circumstances, one test type may be recommended over the other. For more information about how to reduce your risk of getting a false negative result on an at-home COVID-19 antigen test, read our FDA Safety Communication. 1. iHealth COVID-19 Rapid Antigen Test iHealth is another top-rated test brand that has an FDA-authorized at-home test kit for COVID-19. ; ; Catal; Cymraeg; Deutsch; Eesti; ; Espaol; Euskara; ; Franais; ; ; Hrvatski . US Navy mulls adding info warfare specialists on more submarines. The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Quidel QuickVue At-Home OTC . "Most manufacturers have an ability where you can call or check online," Morrissey said. <section jsaction="rcuQ6b: trigger.EGZ8Jb" jscontroller="ThIs3" jsshadow class="XzbSje m586Kb JGNgFd VLrnY eO2Zfd " aria-labelledby="_ypbgzc_i1 _Eq2Xzc_i2" data . For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi. It does not detect the virus. On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. In Vitro Diagnostic EUAs: Overview and Templates, For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). Before sharing sensitive information, make sure you're on a federal government site. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA-authorized at-home COVID-19 diagnostic test, Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Understanding at-home OTC antigen test results, CLIA (Clinical Laboratory Improvement Amendments). Age 2 years and older when collected by an adult, Requires supervision of a telehealth proctor and a smartphone or computer, People with symptoms that began within the last 7 days, People without symptoms. 1 Authorized settings include the following: 2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary. Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests). These include molecular tests,. The FDA is actively researching the accuracy of at-home and self-test kits. Download it here. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test's performance as outlined in the letter. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. It's an antigen test that gives you results in. U.S. FDA 65%8. Tests with "single target" in the attribute column are: Tests with "multiple targets" in the attribute column are: To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for each EUA. medical devices. Enter any combination of fields and select Search. Over the following month and a half, regulators in various countries approved Pfizer's vaccine for emergency use. This table includes information about authorized SARS-CoV-2 serology/antibody tests and other adaptive immune response teststhat have been authorized individually. Here's a look at which at-home COVID tests the CDC says are approved by the FDA, and how long each of the kits are good for: BinaxNOW COVID-19 Ag Card Home Test, 15 months BinaxNOW. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. Everything you need to know about Florida's theme parks and the all-new Attractions Insider podcast! In May 2020, it received EUA from the FDA for another lab-based COVID-19 antibody test that helps detect the IgG antibody to SARS-CoV-2 using the company's Alinity i system. An official website of the United States government, : The prevalence, and remaining unknowns, of the omicron variant have put people on edge and sent them out for testing in numbers that have caused the site at Barnett Park in Orange County to hit capacity hours before the it was scheduled to close two days in a row. Expired at-home COVID tests can lead to inaccurate or invalid test results, but medical experts say to think twice before throwing them away. Authorized devices in the table below are assigned the QKO product code. RT-PCR = reverse transcriptase polymerase chain reaction; LAMP = loop-mediated isothermal amplification; MALDI-TOF = Matrix Assisted Laser Desorption/Ionization - Time of Flight; TMA = Transcription Mediated Amplification; qSTAR = Selective Temperature Amplification Reaction; CRISPR = clustered regularly interspaced short palindromic repeats; Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial containing transport media after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program. A COVID-19 test done with a sample of your blood (serology) only detects if your body has developed antibodies in response to the COVID-19 virus. Using the search box in the EUA tables, you can use keywords to search and filter the type of test or collection kit you are looking for. LIST OF FDA APPROVED COVID-19 TEST KITS FOR COMMERCIAL USE PRESS STATEMENT March 19, 2020 The Food and Drug Administration (FDA) has released today a list of approved COVID-19 test kits for commercial use. M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. {or self-collected at home using the following authorized home collection kit(s): [specific named home collection kit(s) with which the test was validated] when used consistent with the home collection kit's authorization for individuals tested at least once per week}, See Appendix A table below for a list of tests authorized under this EUA. For details about each authorized COVID-19 diagnostic test, see the lists of authorized Molecular Diagnostic Tests and Antigen Diagnostic Tests, as well as the At-Home COVID-19 Diagnostic Tests webpage. Travel requirements to enter the United States are changing, starting November 8, 2021. UPDATE. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. (August 2022) The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Before sharing sensitive information, make sure you're on a federal government site. There are two common types of COVID-19 diagnostic tests: Molecular tests, such as polymerase chain reaction (PCR) and other nucleic acid amplification tests (NAATs) tests, which detect. Authorized by the FDA for at-home use in November 2021, the iHealth at-home COVID antigen test comes with two nasal swabs, test cassettes, fluid vials, and vial caps. People with symptoms that began within the last 7 days. 2023, Charter Communications, all rights reserved. This infographic provides a visualization of data about the coronavirus (COVID-19) diagnostic tests authorized by the FDA. Most authorized at-home OTC COVID-19 tests are antigen tests, and there are also a small number of authorized at-home OTC COVID-19 molecular tests. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about the COVID-19 disease and gain experience with the EUA process for the various types of COVID-19 tests. The TGA has now published the shelf-life information in the table below. On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of. Buy BinaxNOW Covid19 Antigen Self $19.88. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization. Some diagnostic tests use other samples such as mid-turbinate, nasopharyngeal, oropharyngeal, or saliva samples. Molecular tests are more. The announcement made Pfizer and BioNTech the first companies to develop and test a working vaccine for COVID-19. Most authorized at-home OTC COVID-19 tests are antigen tests, and there. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs. People have the option to buy an over-the-counter home COVID-19 test, but experts say they should make sure what they get has been approved by the U.S. Food and Drug Administration. Sienna COVID-19 Antigen Rapid Test Cassette, Clarity COVID-19 Antigen Rapid Test Cassette, OVIOS COVID-19 Antigen Rapid Test Cassette, Spring Health COVID-19 Antigen Rapid Test, Salocor COVID-19 Antigen Rapid Test Cassette. designed to detect only one antigen target, currently either a section of the spike protein or a section of the nucleocapsid protein; more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants. Before sharing sensitive information, make sure you're on a federal government site. Health Canada 50.5%. Find All FDA-Approved Home and Lab Tests You can find information about each home or lab test that FDA has approved or cleared by searching FDA's Database of In Vitro Diagnostic (IVD). Self-tests for COVID-19 give rapid results and can be taken anywhere, regardless of your vaccination status or whether or not you have symptoms. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. 8/24/2021. Below is a list of the 11 tests currently approved by the FDA for use at home: The Food and Drug Administration has released the most current list of approved at-home COVID-19 tests. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs, Remote or Wearable Patient Monitoring Devices EUAs, Ventilators and Ventilator Accessories EUAs, Emergency Use Authorizations for Medical Devices, Molecular Diagnostic Tests for SARS-CoV-2, Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2, Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2, Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing, EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests, Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2, Antigen EUA Revision for Serial (Repeat) Testing, Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2, Individual EUAs for Genotyping Tests for SARS-CoV-2, Serology and Other Adaptive Immune Response Tests for SARS-CoV-2, Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2, Molecular Diagnostic EUA Cover Sheet Template, Molecular Diagnostic Home Specimen Collection Template, Molecular and Antigen Home Use Test Template, Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing, Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies, Policy for Coronavirus Disease-2019 Tests (Revised), Coronavirus (COVID-19) and Medical Devices, SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs, Remote or Wearable Patient Monitoring Devices EUAs, Ventilators and Ventilator Accessories EUAs, Emergency Use Authorizations for Medical Devices, In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2, Molecular Diagnostic Tests for SARS-CoV-2, Serology and Other Adaptive Immune Response Tests for SARS-CoV-2, Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2, Antigen EUA Revisions for Serial (Repeat) Testing, Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD), INDICAID COVID-19 Rapid Antigen At-Home Test, Letter Granting EUA Revision(s) (May 12, 2022), Letter Granting EUA Revision(s) (August 12, 2022), Letter Granting EUA Revision(s) (December 22, 2022), Letter Granting EUA Revision(s) (March 7, 2022), Letter Granting EUA Revision(s) (April 28, 2022), Letter Granting EUA Revision(s) (June 24, 2022), Letter Granting EUA Revision(s) (October 14, 2022), Letter Granting EUA Revision(s) (March 29, 2022), Letter Granting EUA Revision(s) (April 4, 2022), Letter Granting EUA Revision(s) (July 8, 2022), Letter Granting EUA Revision(s) (January 11, 2023), Letter Granting EUA Revision(s) (November 4, 2022), Letter Granting EUA Revision(s) (January 20, 2023), Letter Granting EUA Revision(s) (October 15, 2021), Letter Granting EUA Revision(s) (April 20, 2022), Letter Granting EUA Revision(s) (September 2, 2022), Letter Granting EUA Revision(s) (November 18, 2022), Letter Granting EUA Revision(s) (August 24, 2022), Letter Granting EUA Amendment(s) (June 9, 2020), Letter Granting EUA Amendment(s) (July 17, 2020), Viral MutationRevision Letter - September 23, 2021, BD Veritor System for Rapid Detection of SARS-CoV-2, Letter Granting EUA Amendment(s) (July 23, 2020), Letter Granting EUA Revision(s) (December 10, 2021), Letter Granting EUA Revision(s) (January 26, 2021), Letter Granting EUA Revision(s) (February 17, 2022), Letter Granting EUA Revision(s) (April 6, 2021), Letter Granting EUA Revision(s) (January 7, 2022), Letter Granting EUA Revision(s) (February 4, 2022), Letter Granting EUA Revision(s) (November 21, 2022), Letter Granting EUA Revision(s) (March 15, 2021), Letter Granting EUA Revisions(s) (July 16, 2021), Letter Granting EUA Revision(s) (December 2, 2021), Letter Granting EUA Revision(s) (January 17, 2023), VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack, Letter Granting EUA Revision(s) (November 16, 2021), BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, Letter Granting EUA Revision(s) (July 21, 2022), Letter Granting EUA Revision(s) (September 23, 2022), Letter Granting EUA Revision(s) (December 21, 2022), Letter Granting EUA Revision(s) (July 12 2021), Letter Granting EUA Revision(s) (February 16, 2022), Letter Granting EUA Revision(s) (October 25, 2022), Celltrion DiaTrust COVID-19 Ag Rapid Test, Letter Granting EUA Revision(s) (August 11, 2022), Letter Granting EUA Revision(s) (March 3, 2022), Letter Granting EUA Revision(s) (May 26, 2022), Letter Granting EUA Revision(s) (December 23, 2022), Sienna-Clarity COVID-19 Antigen Rapid Test Cassette, Letter Granting EUA Revision(s) (December 17, 2021), Letter Granting EUA Revision(s) (June 09, 2022), Letter Granting EUA Revision(s) (August 3, 2022), Letter Granting EUA Revision(s) (February 01, 2023), Letter Granting EUA Revision(s) (June 13, 2022), Letter Granting EUA Revision(s) (February 21, 2023), Letter Granting EUA Revision(s) (January 14, 2022), Letter Granting EUA Revision(s) (February 22, 2022), Letter Granting EUA Revision(s) (December 28, 2022), Letter Granting EUA Revision(s)(August 23, 2021), Letter Granting EUA Revision(s) (January 22, 2022), Letter Granting EUA Revisions(s) (June 7, 2022), Letter Granting EUA Revision(s) (August 29, 2022), Letter Granting EUA Revision(s) (September 28, 2022), Letter Granting EUA Revision(s) (Feburary 1, 2022, CLINITEST Rapid COVID-19 Antigen Self-Test, Letter Granting EUA Revision(s) (June 23, 2022, Letter Granting EUA Revision(s) (October 12, 2022), Letter Granting EUA Revision(s) (December 27, 2022), MaximBio ClearDetect COVID-19 Antigen Home Test, Letter Granting EUA Revision(s) (March 30, 2022), Letter Granting EUA Revision(s) (July 22, 2022), Letter Granting EUA Revision(s) (December 16, 2022), Letter Granting EUA Revision(s) (January 09, 2023), Letter Granting EUA Revision(s) (May 4, 2022), Letter Granting EUA Revision(s) (December 2, 2022), Letter Graning EUA Revision(s) (February 24, 2023), ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag), Letter Granting EUA Revision(s) (August 19, 2022), Letter Granting EUA Revision(s) (October 18, 2022), Speedy Swab Rapid COVID-19 Antigen Self-Test, Letter Granting EUA Revision(s) (August 23, 2022).

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