list of fda approved covid tests

Also in May, it received EUA from the FDA for a molecular COVID-19 test for use on the company's Alinity molecular laboratory instrument. vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. 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. Requires a Cue Cartridge Reader (sold separately). For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. The table includes links to home use instructions for each test. "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. For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). STATEN ISLAND, N.Y. -- The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories. 263a, that meet requirements to perform high complexity tests. The tests detect different parts of the Covid virus and vary in sensitivity. SAN DIEGO Pilot projects launched last year to examine how information warfare gurus can enhance submarine operations may yield long-term plans. US Navy mulls adding info warfare specialists on more submarines. 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. 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. "Most manufacturers have an ability where you can call or check online," Morrissey said. 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. View graphs and map for Testing in U.S. for COVID-19. COVID-19 Testing Update: Today, our administration announced that beginning January 15, 2022, individuals covered by a health insurance plan who purchase an FDA-approved, over-the-counter COVID-19 . 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. 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, : They had the sniffles, and with a grandparent set to visit he wanted to minimize the risk that they were infectious. There's a new federal resource to get free FDA-authorized coronavirus test kits. 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. The .gov means its official.Federal government websites often end in .gov or .mil. To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization. Results are usually available in 30 minutes or less. H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. In 1947, Salk accepted a professorship at the University of Pittsburgh School of . 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. The types of samples include: Saliva samples are collected by spitting into a tube rather than using a nose or throat swab. Quidel QuickVue At-Home OTC . Go to COVIDtests.gov or call 1-800-232-0233 (TTY 1-888-720-7489) to order your free COVID test kits from the federal government. (August 2022) But the move came after tests last month showed the masks didn't meet standards. Online, if you click to . OTC - Over The Counter. Download it here. Authorized devices in the table below are assigned the QKO product code. According to the FDA's website, Elabscience at-home tests have yet to be FDA-approved. Warner-Lambert, which merged with Pfizer in 2000, . 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. Before sharing sensitive information, make sure you're on a federal government site. 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. Buy BinaxNOW Covid19 Antigen Self $19.88. Please keep in mind that merely contacting Nelson Mullins Riley & Scarborough LLP will not establish an attorney-client relationship. Nelson Mullins cannot represent you until the firm knows there would not be a conflict of interest, and the firm determines that it is otherwise able to accept the engagement. People with symptoms that began within the last 4 days. H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. The letter also eliminates a Condition of Authorization concerning the collection of additional . It does not detect the virus. 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. 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 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. You can use the Test Type drop down box to select a Type of Test. More research is needed to determine what, if anything, antibody tests can tell us about a persons immunity. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. . (TB), all tests and examinations for TB diagnosis should be pursued without delay, regardless of JYNNEOS . 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. The FDA has updated expiration dates for those tests. Before sharing sensitive information, make sure you're on a federal government site. 263a, that meet requirements to perform moderate complexity tests. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. The site is secure. On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. In this photo illustration, an at-home COVID-19 test by . 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. Get hyperlocal forecasts, radar and weather alerts. ORAL) saliva collection devices, Express Gene 2019-nCoV RT-PCR Diagnostic Panel, Gravity Diagnostics SARS-CoV-2 RT-PCR Assay, Pixel by LabCorp COVID-19 Test Home Collection Kit, Letter Granting EUA Revision(s) (April 1, 2022), Letter Granting EUA Revision(s) (July 8, 2022), Letter Granting EUA Revision(s) (November 1, 2022), Letter Granting EUA Revision(s) (February 12, 2021), Letter Granting EUA Revision(s) (November 17, 2021), Letter Granting EUA Revision(s) (February 24, 2021), Letter Granting EUA Revision(s) (February 14, 2023), Letter Granting EUA Revision(s) (March 9, 2021), Letter Granting EUA Revision(s) (March 25, 2021), Letter Granting EUA Revision(s) (May 5, 2022), Letter Granting EUA Revision(s) (April 30, 2021), Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit, Letter Granting EUA Revision(s) (March 3, 2021), BD MAX COVID-19 ASSAY (Authorized by HHS/OASH), PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH), Letter Granting EUA Revision(s) (March 4, 2022), Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits, Everlywell COVID-19 Test Home Collection Kit DTC, Cue COVID-19 Test for Home and Over The Counter (OTC) Use, Letter Granting EUA Revision(s) (June 10, 2021), Letter Granting EUA Revision(s) (July 1, 2021), Letter Granting EUA Revision(s) (February 7, 2022), Letter Granting EUA Revision(s) (March 30, 2022), NxTAG Respiratory Pathogen Panel + SARS-CoV-2, Letter Granting EUA Revision(s) (January 4, 2023), CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3), Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2 -Amendment Letter, Gravity Diagnostics COVID-19 Test Home Collection Kit, Color COVID-19 Self-Swab Collection Kit DTC, Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC, NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, Letter Granting EUA Revision(s) (December 17, 2021), SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH), Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit, Letter Granting EUA Revision(s) (March 3, 2022), Letter Granting EUA Revision(s) (November 4, 2022), PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit, Clinical Enterprise SARS-CoV-2 RT-PCR Assay, Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC, Letter Granting EUA Revision(s) (May 6, 2021), Color COVID-19 Self-Swab Collection Kit with Saline, Letter Granting EUA Revision(s) (January 31, 2022), Letter Granting EUA Revision(s) (June 15, 2022), Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test, Letter Granting EUA Revision(s) (June 2, 2021), Kaiser Permanente High Throughput SARS-CoV-2 Assay, Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC, WREN Laboratories COVID-19 Saliva Test Collection Kit DTC, cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2), Everlywell COVID-19 & Flu Test Home Collection Kit, Letter Granting EUA Revision(s) (March 1, 2022), Letter Granting EUA Revision(s) (September 21, 2022), Letter Granting EUA Revision(s) (October 22, 2021), Kwokman Diagnostics COVID-19 Home Collection Kit, Life Sciences Testing Center COVID-19 Test, Letter Granting EUA Revision(s) (March 25, 2022), Letter Granting EUA Revision(s) (August 2, 2022), Letter Granting EUA Revision(s) (September 9, 2022), Letter Granting EUA Revision(s) (November 8, 2022), Quest COVID-19 PCR Test Home Collection Kit, Letter Granting EUA Revision(s) (July 7, 2022), Letter Granting EUA Revision(s) (October 6, 2022), Test Yourself DC At-Home COVID-19 Collection Kit, Letter Granting EUA Revision(s) (May 25, 2022), OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2), Labcorp Seasonal Respiratory Virus RT-PCR Test, Letter Granting EUA Revision(s) (November 23, 2022), cobas SARS-CoV-2 Duo for use on the cobas 6800/8800 Systems, Diversified Medical Healthcare SARS-CoV-2 Assay, Hi-Sense COVID-19 Molecular Testing Kit 1.0, BD Respiratory Viral Panel for BD MAX System, LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay, The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector. FDA recommends repeating COVID-19 at-home test in 48 hours if negative The Food and Drug Administration yesterday advised people who get a negative result from an at-home COVID-19 antigen test to test themselves again after Headline CDC updates public health guidance for preventing COVID-19 illness In some cases, the expiration date for a test may be extended. 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. Some, but not all manufacturers of approved rapid antigen tests (RATs) have extended the shelf-life of their products. The Food and Drug Administration has authorized the first over-the-counter at-home test that can detect and differentiate between a test result for flu and a test result for COVID-19. 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. 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. Some diagnostic tests use other samples such as mid-turbinate, nasopharyngeal, oropharyngeal, or saliva samples. You can find information about each home or lab test that FDA has approved or cleared by searching FDAs Database of In Vitro Diagnostic (IVD) Tests. More information is available here. 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. Additional information can be found on the FAQs on Testing for SARS-CoV-2 page. The latest Arizona headlines, breaking news, in-depth investigations, politics, and local community stories that matter to you. The site is secure. Travel . Currently the FDA HAS NOT approved any at-home or self-test kits. This page provides information on types of COVID-19 Tests and Supplies for laboratory personnel. W - Patient care settings operating under a CLIA Certificate of Waiver. The test is to be performed two times over three days (serial testing). SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. For additional performance information about EUA authorized serology/antibody tests, please see the EUA Authorized Serology Test Performance page. The expiration date is set at the end of the shelf-life. A few weeks ago, a ProPublica reporter decided to test his kids for COVID-19. 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. To be on this list, a lab must meet 4 criteria: Lab has a valid California clinical laboratory license and a CLIA certificate. An official website of the United States government, : For more information about antibody testing, visit Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers. M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. medical devices. The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. 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. M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 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. The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021. 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. . Diagnostic Covid tests fall into two buckets: molecular tests and antigen tests. Diagnostics able to detect current, active infections are typically antigen- and molecular-based tests. For Test Name and Manufacturer: enter a single word (e.g., analyzer) or an exact phrase (e.g., acme analyzer). In a statement, the agency is urging people to stop using the LuSys Laboratories COVID-19 Antigen Test and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. Click here for a full list of FDA approved at-home COVID tests and their up-to-date expiration dates. 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). Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Ag Card Home Test, Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Antigen Self Test, Access Bio, Inc.:CareStart COVID-19 Antigen Home Test, ACON Laboratories, Inc:Flowflex COVID-19 Antigen Home Test, Aptitude Medical Systems Inc.:Metrix COVID-19 Test, Becton, Dickinson and Company (BD):BD Veritor At-Home COVID-19 Test, Celltrion USA, Inc.:Celltrion DiaTrust COVID-19 Ag Home Test, CTK Biotech, Inc.:ImmuView COVID-19 Antigen Home Test, Cue Health Inc.:Cue COVID-19 Test for Home and Over The Counter (OTC) Use, Genabio Diagnostics Inc.:Genabio COVID-19 Rapid Self-Test Kit, iHealth Labs, Inc.:iHealth COVID-19 Antigen Rapid Test, InBios International Inc:SCoV-2 Ag Detect Rapid Self-Test, Lucira Health, Inc:Lucira CHECK-IT COVID-19 Test Kit, Maxim Biomedical, Inc.:MaximBio ClearDetect COVID-19 Antigen Home Test, Mologic, Inc.:COVI-Go SARS-CoV-2 Ag Self-Test, OraSure Technologies, Inc.:InteliSwab COVID-19 Rapid Test, PHASE Scientific International, Ltd.:INDICAID COVID-19 Rapid Antigen At-Home Test, Quidel Corporation:QuickVue At-Home OTC COVID-19 Test, SD Biosensor, Inc.:Pilot COVID-19 At-Home Test 1, Siemens Healthineers:CLINITEST Rapid COVID-19 Antigen Self-Test, Watmind USA:Speedy Swab Rapid COVID-19 Antigen Self-Test, Xiamen Boson Biotech Co., Ltd.:Rapid SARS-CoV-2 Antigen Test Card, ANP Technologies, Inc.:NIDS COVID-19 Antigen Home Test, Beijing Hotgen Biotech Co., Ltd.:Hotgen COVID-19 Antigen Home Test, Azure Biotech Inc.:Fastep COVID-19 Antigen Home Test, Oceanit Foundry LLC:ASSURE-100 Rapid COVID-19, Advin Biotech Inc.:Advin COVID-19 Antigen Test @Home, GenBody Inc.:GenBody COVID-19 Ag Home Test, Lucira Health, Inc.:Lucira COVID-19 & Flu Home Test, An official website of the United States government, : Please discuss this issue on the article's talk page. 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,. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. "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.". Here is the commission's guidance as well as how to understand the tests: Check whether the COVID-19 test is FDA-approved . Antigen multi-analyte respiratory panel tests authorized in the table below are assigned the QMN product code. 263a, that meet requirements to perform moderate complexity tests. 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. 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). Rapid tests detect protein. BinaxNOW, however,. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2, Molecular Diagnostic Tests for SARS-CoV-2, Individual EUAs for Serology and Other AdaptiveImmune Response Tests for SARS-CoV-2, Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2, Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD), EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG), Letter Granting EUA Revision(s) (March 1, 2022), Letter Granting EUA Amendment(s) (May 9, 2020), Letter Granting EUA Amendment(s) (June 22, 2020), Letter Granting EUA Revision(s) (September 18, 2020), Letter Granting EUA Revision(s) (December 1, 2020), Viral Mutation Revision Letter (September 23, 2021), VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, Letter Granting EUA Revision(s) (October 30, 2020), Letter Granting EUA Revision(s) (January 29, 2021), Letter Granting EUA Amendment(s) (July 22, 2020), Letter Granting EUA Revision(s) (October 19, 2020), Letter Granting EUA Revision(s) (October 7, 2021), VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, Letter Granting EUA Revision(s) (May 20, 2020), Letter Granting EUA Revision(s) (October 23, 2020), Letter Granting EUA Amendment(s) (July 21, 2020), Letter Granting EUA Revision(s) (February 25, 2022), New York SARS-CoV Microsphere Immunoassay for Antibody Detection, Letter Granting EUA Amendment(s) (June 4, 2020), Letter Granting EUA Revision(s) (July 13, 2021), COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), RightSign COVID-19 IgG/IgM Rapid Test Cassette, Letter Granting EUA Amendment(s) (July 23, 2020), Letter Granting EUA Revision(s) (August 31, 2020), Dimension Vista SARS-CoV-2 Total antibody assay (COV2T), Letter Granting EUA Amendment(s) (August 7, 2020), Dimension EXL SARS-CoV-2 Total antibody assay (CV2T), Letter Granting EUA Revision(s) (April 21, 2022), Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit, Letter Granting EUA Amendment(s) (August 3, 2020), Letter Granting EUA Revision(s) (October 17, 2020), LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), Letter Granting EUA Revision(s) (August 12, 2020), Letter Granting EUA Revision(s) (December 2, 2020), Letter Granting EUA Revision(s) (February 14, 2022), Assure COVID-19 IgG/IgM Rapid Test Device, Letter Granting EUA Revision(s) (January 31, 2022), Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette, Letter Granting EUA Revision(s) (July 12, 2021), Letter Granting EUA Revision(s) (March 9, 2022), BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test, Letter Granting EUA Revision(s) (November 6, 2020), Letter Granting EUA Revision(s) (October 31, 2020), Letter Granting EUA Revision(s) (March 19, 2021), BioCheck SARS-CoV-2 IgG and IgM Combo Test, Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test, Letter Granting EUA Revision(s) (November 2, 2021), Letter Granting EUA Revision(s) (November 19, 2021), BioCheck SARS-CoV-2 IgM Antibody Test Kit, BioCheck SARS-CoV-2 IgG Antibody Test Kit, Letter Granting EUA Revision(s) (November 10, 2020), Letter Granting EUA Revision(s) (November 5, 2021), Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit, OmniPATH COVID-19 Total Antibody ELISA Test, Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2, cPass SARS-CoV-2 Neutralization Antibody Detection Kit, Letter Granting EUA Revision(s) (February 1, 2022), COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit, Letter Granting EUA Revision(s) (May 4, 2021), Letter Granting EUA Revision(s) (February 9, 2022), Letter Granting EUA Revision(s) (August 24, 2022), Innovita 2019-nCoV Ab Test (Colloidal Gold), Letter Granting EUA Revision(s) (June 28, 2021), MidaSpot COVID-19 Antibody Combo Detection Kit, Letter Granting EUA Revision(s) (January 25, 2021), Letter Granting EUA Revision(s) (February 5, 2021), Letter Granting EUA Revision(s) (April 12, 2021), Letter Granting EUA Revision(s) (July 29, 2021), Letter Granting EUA Revision(s) (April 2, 2021), Letter Granting EUA Revision(s) (April 26, 2021), Letter Granting EUA Revision(s) (July 21, 2022), COVID-19 Self-Collected Antibody Test System, Letter Granting EUA Revision(s) (June 24, 2021), ZEUS ELISA SARS-CoV-2 Total Antibody Test System, Letter Granting EUA Revision(s) (February 28, 2022), VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator, Letter Granting EUA Revisions(s) (September 8, 2021, Letter Granting EUA Revisions(s) (June 29, 2022), VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators, Letter Granting EUA Revision(s) (August 31, 2022), Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit, SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests, IgG, Lateral Flow, Fingerstick Whole Blood, Wadsworth Center, New York State Department of Health, IgM and IgG Lateral Flow, Fingerstick Whole Blood, ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit, IgM and IgG, Lateral Flow, Fingerstick Whole Blood.