(a Siemens Healthineers Company), Real-time RT-PCR, Screening, Pooling, Multiple Targets, Real-time RT-PCR, Home Collection, Saliva, Pooling, Multiple Targets, TMA, chemiluminescent, Pooling, Screening, Multiple Targets, Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening, Pooling, Multiple Targets, RT, Isothermal amplification, Screening, Single Target. The most important thing to consider when looking for an updated expiration date is the brand or manufacturer of the at-home COVID test. Most authorized at-home OTC COVID-19 tests are antigen tests, and there. After embedding information warfare sailors and officers aboard two subs, there are now talks "to invest full-time, probably, in . Travel requirements to enter the United States are changing, starting November 8, 2021. The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Antibody (or serology) tests look for antibodies in your blood that your immune system produced in response to SARS-CoV-2, the virus that causes COVID-19. To see complete information on smaller screens, select the blue plus (+) button beside the test name. You can read more about the individual types of tests, safety communications and how to interpret your test results at the links below: The FDA encourages health care professionals and patients to report adverse events or side effects as well as performance issues related to the use of COVID-19 tests or other medical products to the FDAs MedWatch Safety Information and Adverse Event Reporting Program: Subscribe to receive FDA Consumer Update email notifications. 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. There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The tests detect different parts of the Covid virus and vary in sensitivity. Most Food and Drug Administration approved at-home COVID tests have a longer lifespan than previously anticipated. Antigen and Molecular Tests for COVID-19 The diagnostic testing field for COVID-19 is rapidly evolving, with many tests focused on diagnosing patients with active viral infections. Healthcare in the United States - Wikipedia Self-Testing At Home or Anywhere | CDC Sara Humm, the senior planner with the Columbia/Boone County Public Health and Human Services said originally, the at-home tests had an expiration date between four and six months. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. Negative results for severe acute respiratory syndrome coronavirus 2 and influenza B, if it is necessary for patient management, should be confirmed with an authorized molecular test performed in an approved laboratory, the FDA said. Authorized EUA devices in the table below for SARS-CoV-2 antigen diagnostic tests are assigned the QKP product code. To see complete information on smaller screens, select the blue plus (+) button beside the test name. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. Developers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. Testing and other protective steps like wearing a mask and COVID-19 vaccination are important to stop the spread of COVID-19 infection. Lab is running FDA EUA molecular or antigen diagnostic tests. There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. It's official: Get free COVID test kits at COVIDtests.gov F.D.A. Bans Faulty Masks, 3 Weeks After Failed Tests Most over-the-counter COVID-19 tests are antigen tests. The .gov means its official.Federal government websites often end in .gov or .mil. It quickly pivoted to a health professionals-only test and then rereleased its kit to the public after the. The standard regimen is the FDA-approved dosing regimen. Alternative Brand Names: CVS Health At Home COVID-19 Test Kit and Walgreens At-Home COVID-19 Test Ket, People with symptoms that began within the last 6 days. Another way to find the updated list of expiration dates is on the FDA's website. If you think you need a COVID-19 diagnostic test, you can find a community testing site in your state. The types of samples include: Saliva samples are collected by spitting into a tube rather than using a nose or throat swab. Receive a detailed news briefing each morning and evening along with our Attractions Insider briefing on Fridays on our app, approved by the U.S. Food and Drug Administration, California Consumer Limit the Use of My Sensitive Personal Information, California Consumer Do Not Sell or Share My Personal Information. 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. These are PCR based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. Here is the commission's guidance as well as how to understand the tests: Check whether the COVID-19 test is FDA-approved . 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. March 3, 2023 - The Top Line - Omny.fm Some tests, including most antigen tests, can be performed completely at home, giving you results within minutes, without needing to send your sample to a laboratory. Our Spectrum News app is the most convenient way to get the stories that matter to you. Viral Mutation Revision Letter September 23, 2021. FDA lists all over-the-counter COVID-19 tests authorized for home use "The dates that were printed were very conservative, but it's been extended on many of those products," Bill Morrissey, the managing pharmacist at Kilgore's Medical Pharmacy in Columbia, said. Requires a Cue Cartridge Reader (sold separately). Find All FDA-Approved Home and Lab Tests | FDA - U.S. Food and Drug Where a test was previously authorized for testing of asymptomatic individuals (for example, individuals without symptoms or other epidemiological reasons to suspect COVID-19), the test is now authorized for use at least three times over five days with at least 48 hours between tests. 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. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA. Walmart. You can also use an FDA-authorized at-home COVID-19 diagnostic test which gives you the option of self-testing where it is convenient for you. Everything you need to know about Florida's theme parks and the all-new Attractions Insider podcast! The FDA released an initial version of this infographicfor 2020. Please read the layout guide and lead section guidelines to ensure the section will still be inclusive of all essential details. 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). OTC - Over The Counter. H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. , 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. At-Home OTC COVID-19 Diagnostic Tests | FDA The test is to be performed two times over three days (serial testing). 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. 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. The templates reflect the FDA's current thinking on the data and information that developers should submit to facilitate the EUA process. Before sharing sensitive information, make sure you're on a federal government site. Buy BinaxNOW Covid19 Antigen Self $19.88. For most molecular COVID-19 diagnostic tests, you go to a testing site to have your sample collected and for others you can collect your own sample at home using a home collection kit and mail it to a laboratory for testing. Rapid tests detect protein. . An antigen test, frequently used for rapid testing, detects viral proteins found in SARS-CoV-2. This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. Ron DeSantis told Fox News six words about Donald Trump attacking him 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. Members of the public can submit questions about the templates to CDRH-EUA-Templates@fda.hhs.gov, or they can submit comments regarding the templates to the public docket established for the guidance Policy for Coronavirus Disease-2019 Tests (Revised). 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. Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing aliquots of media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were 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 and placed in individual vials when tested at least once per week. 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. The test is to be performed two times over three days (serial testing). H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. In some cases, the expiration date for a test may be extended. 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. Types of Approved COVID-19 Tests - COVID-19 Information Independent Evaluations of COVID-19 Serological Tests Tests Used In Clinical Care, Recalls, Market Withdrawals and Safety Alerts, Safety Issue on Magellan Diagnostics LeadCare Testing Systems, enter a search term (for example the type of test, name, company, or other key word) in the blank space, review the listing of products that match your search term, select any products for additional information (including Decision Summaries). The site is secure. Health Canada 50.5%. USGC Saliva Test Kit, hims/hers Saliva Test Kit, AZOVA At-Home COVID-19 Test Collection Kit, Wellness 4 Humanity SDNA-1000 Saliva Collection Kit, AZOVA P23 At-Home COVID-19 Test Collection Kit, binx health (powered by P23) At-home Saliva COVID-19 Test Collection Kit for the Group Setting, Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 . 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. As new tests are authorized for use, they are added to these tables so that anyone can access up-to-date information on all authorized tests and collection kits. 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. Headline The site is secure. Antigen and Molecular Tests for COVID-19 - COVID-19 Testing Toolkit On November 1, 2022, the U.S. Food and Drug Administration (FDA) updated the emergency use authorizations (EUAs) of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat or serial testing. The .gov means its official.Federal government websites often end in .gov or .mil. For three weeks . This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. They had the sniffles, and with a grandparent set to visit he wanted to minimize the risk that they were infectious. This page provides information on types of COVID-19 Tests and Supplies for laboratory personnel. This table includes information about authorized SARS-CoV-2 serology/antibody tests and other adaptive immune response teststhat have been authorized individually. . Here are nine FDA-authorized at-home COVID-19 tests you can order right now: iHealth COVID-19 Rapid Antigen Test, 2 Pack, $17.98; amazon.com On/Go At-Home COVID-19 Rapid Antigen Test,. 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. Individuals ages 14 and older . The FDA said the tests. If the Expiration Date column says that the shelf-life is "extended," there is a link to "updated expiration dates" where you can find a list of the original expiration dates and the new expiration dates. 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. Real-time RT-PCR, Saliva, Multiple Targets, University of Alabama at Birmingham Fungal Reference Lab, Home Collection Kit, Direct to Consumer (DTC), Screening, Centers for Disease Control and Prevention (CDC), Real-time RT-PCR, Multi-analyte, Single Target, UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin, Real-time RT-PCR, Home Collection, Single Target, TMA, chemiluminescent, Home Collection, Multiple Targets, RT, LAMP, Home Collection, Screening, Multiple Targets, Real-time RT-PCR, Home Collection, Saliva, Single Target, University of California San Diego Health, RT-PCR and MALDI-TOF Mass Spec., Home Collection, Multiple Targets, TMA, chemiluminescent, Pooling, Multiple Targets, George Washington University Public Health Laboratory, Real-time RT-PCR, Multiple Targets, Home Collection, Real-time RT-PCR, Pooled Serial Screening - Swab, Pooled Serial Screening - Media, Multiple Targets, RT, non-isothermal nucleic acid amplification qSTAR, Single Target, Real-time RT-PCR, Saliva, Home Collection, Screening, Pooling, Single Target, Texas Department of State Health Services, Laboratory Services Section, RT-PCR, Home Collection, Saliva, Multiple Targets, RT, amplification, T2 Magnetic resonance, Single Target, Home Collection Kit, Screening, Multiple Targets, Real-time RT-PCR, Pooling, Home Collection, Multiple Targets. How to Buy COVID-19 Tests Online in 2022 - The Hollywood Reporter Where a test was previously authorized for testing of symptomatic individuals (for example, within the first [number specific to each test] days of symptom onset), the test is now authorized for use at least twice over three days with at least 48 hours between tests. KOMU 8 is a full-powered NBC affiliate operating as an independent commercial property. COVID test warning: FDA warns of false results with LuSys Laboratories 5 FDA-Authorized At-Home COVID-19 Tests You Can Buy on Amazon - InStyle However, antibody test results are not reported on the state's dashboard anyway. 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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