list of fda approved covid tests

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. The FDA authorized three COVID-19 vaccines (Pfizer, Moderna and Johnson & Johnson) to answer an urgent need to protect people from the coronavirus pandemic, which was (and continues to be) a public health emergency. For three weeks . On November 1, 2022, the FDA revised the authorized uses and required updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests. 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. The latest Arizona headlines, breaking news, in-depth investigations, politics, and local community stories that matter to you. 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. 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. Diagnostic tests can show if you have an active COVID-19 infection. Different tests are authorized to be used with different types of samples. The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021. People with symptoms that began within the last 7 days. There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. 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. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. They give your result in a few minutes and are different from . 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 . designed to detect more than one section of the proteins that make up SARS-CoV-2; more likely to continue to perform as labeled as new variants emerge. Walmart. Another way to find the updated list of expiration dates is on the FDA's website. 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. Jiangsu Bioperfectus Technologies Co., Ltd. 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. More information is available here. Below is a list of the 11 tests currently approved by the FDA for use at home: CareStart COVID-19 Antigen Home Test iHealth COVID-19 Antigen Rapid Test BD Veritor At-Home COVID-19. 2023, Charter Communications, all rights reserved. This page has information about at-home over-the-counter (OTC) COVID-19 diagnostic 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. 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. 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. "This is a huge milestone," Dr. Michael Mina, a Harvard epidemiologist who has been. Most authorized at-home OTC COVID-19 tests are antigen tests, and there. "So if you have tests at home that you've had for a while, and they look like they just expired, or they're expiring soon, you can check in with that manufacturer.". 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. 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. 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. 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. 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. Venous blood samples are typically collected at a doctors office or clinic. US Navy mulls adding info warfare specialists on more submarines. "There's a page on their website where you can look up by the name of the test, and see what that expiration date extension is," Humm said. The .gov means its official.Federal government websites often end in .gov or .mil. 263a, that meet requirements to perform moderate complexity tests. At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target,Telehealth Proctor Supervised (optional), Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Multiple Targets, Lateral Flow, Visual Read, Serial Screening, Single Target, Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Fluorescence, Instrument Read, Serial Screening, Single Target, Chromatographic Digital Immunoassay, Instrument Read, Serial Screening, Single Target, Microfluidic Immunofluorescence Assay, Instrument Read, Serial Screening, Single Target, Lateral Flow, Visual Read, Single Target, Serial Screening, Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte, Single Target, Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA), Single Target, Lateral flow immunoluminescent assay, instrument read, Serial Screening, Single Target, Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target, Chemiluminescence Immunoassay, Instrument Read, Single Target, Lateral Flow, Visual Read, Multi-analyte, Single Target, Lateral Flow, Visual Read, Prescription Home Testing, Single Target, Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte, Single Target, Bulk Acoustic Wave (BAW) Biosensor, Instrument Read, Serial Screening, Single Target, Lateral Flow, Visual Read, Serial Screening, Multiple Targets, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Lateral Flow, Visual Read, Serial Screening, Single Target, Lateral Flow, Fluorescence, Instrument Read, Single Target, Lateral Flow, Visual Read,Serial Screening, Single Target, Digital Lateral Flow, Fluorescence, Instrument Read, Single Target, Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target. The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. 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. By, Discover Nature (Missouri Department of Conservation), Innovations in Health Care from the University of Missouri. The site is secure. The FDA said the tests. 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. 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. The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. More information is available here. 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). Before sharing sensitive information, make sure you're on a federal government site. Some antibody tests use blood samples from a finger stick. "COVID-19 is characterized by high levels of inflammatory markers, including C-reactive protein (CRP), and increased levels of inflammatory cytokines and chemokines. 263a, that meet requirements to perform high complexity tests. 3 Abbreviations: CLIA = chemiluminescence immunoassay; ELISA = enzyme-linked immunosorbent assay; ECLIA = electrochemiluminescence immunoassay; FMIA = fluorescent microsphere Immunoassay, CMIA = chemiluminescent microparticle immunoassay; ELFA = enzyme-linked fluorescence assay. The site is secure. KOMU 8 is a full-powered NBC affiliate operating as an independent commercial property. Please keep in mind that merely contacting Nelson Mullins Riley & Scarborough LLP will not establish an attorney-client relationship. This article's lead section may be too long for the length of the article. Most Food and Drug Administration approved at-home COVID tests have a longer lifespan than previously anticipated. For more information about antibody testing, visit Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Authorized at-home OTC tests are available without a prescription and are typically available online or at local stores. The table includes links to home use instructions for each test. People with symptoms that began within the last 4 days. These are PCR based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. Diagnostic Covid tests fall into two buckets: molecular tests and antigen tests. When using a COVID-19 antigen diagnostic test, 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 test is to be performed two times over three days (serial testing), Alternate brand name: On/go COVID-19 Antigen Self-Test, Alternate brand name: On/Go One COVID-19 Antigen Home Test, Requires a Metrix Reader (sold separately). In some cases, the expiration date for a test may be extended. . 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. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. To see complete information on smaller screens, select the blue plus (+) button beside the test name. However, antibody test results are not reported on the state's dashboard anyway. Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. Travel requirements to enter the United States are changing, starting November 8, 2021. Learn More. (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. Here is the commission's guidance as well as how to understand the tests: Check whether the COVID-19 test is FDA-approved . An official website of the United States government, : 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. FDA Advisory No.2021-2094 || List of COVID-19 Test Kits with FDA Special Certification and Performance Validation Conducted and/or Recommended by the Research Institute for Tropical Medicine (RITM) - Food and Drug Administration designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome; more likely to continue to perform well when new variants emerge. Some at-home rapid tests on the FDA-approved list that could arrive . 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 Food and Drug Administration prohibited 65 manufacturers from selling masks for medical use. Another way to find the updated list of expiration dates is on the FDA's website. An official website of the United States government, : The November 1, 2022 revision requires test developers in the scope of the revision to take certain actions, including submitting a supplemental EUA request to the FDA with updated labeling to reflect the revised authorized uses, as follows: Repeat Testing Revision Letter - November 1, 2022, An official website of the United States government, : The site is secure. Click here for a full list of FDA approved at-home COVID tests and their up-to-date expiration dates. 263a, that meet requirements to perform high complexity tests. In Vitro Diagnostic EUAs: Overview and Templates. 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. There are two common types of COVID-19 diagnostic tests: Samples for COVID-19 diagnostic tests are typically collected using an anterior nares (nasal) swab sample. The site is secure. Since the start of. The test is to be performed two times over three days (serial testing). 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. 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. On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent. 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. Be sure to check the At-Home OTC COVID-19 Diagnostic Tests website for information on expiration dates, who can use the test, and other details that may help you decide what test is right for you. COVID-19 Tests and Collection Kits Authorized by the FDA. 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. Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The test is to be performed two times over three days (serial testing). The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. 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. The .gov means its official.Federal government websites often end in .gov or .mil. 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). For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs. The revised Letter of Authorization establishes one additional Condition of Authorization and also eliminates one Condition of Authorization that is no longer needed. Once you've confirmed your vitamin D levels via testing, adjust your sun exposure and/or vitamin D3 supplementation accordingly. The test is to be performed two times over three days (serial testing). And not every authorized vaccine becomes fully approved. Before sharing sensitive information, make sure you're on a federal government site. Health Canada 50.5%. Samples for antibody tests are typically collected by a doctor or other medical professional by taking blood from a finger stick or your vein. Viral Mutation Revision Letter September 23, 2021. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. Additional information can be found on the FAQs on Testing for SARS-CoV-2 page. Lab is submitting data to CalREDIE (either . 8/24/2021. 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. 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. 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. 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. 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. databases. For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Blood samples are only used to test for antibodies and not to diagnose COVID-19. 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). The FDA is actively researching the accuracy of at-home and self-test kits. 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. Travel . Templates for EUA submissions for several types of COVID-19 tests are available to help facilitate the preparation, submission, and authorization of an EUA request: These templates are part of the Policy for Coronavirus Disease-2019 Tests (Revised),which also includes additional policies specific to this public health emergency. Fox News Channel's Jesse Watters interviewed DeSantis Tuesday evening to discuss his book as well as his plans moving forward. 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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