{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. Since the start of. Antibody tests should not be used to diagnose a current SARS-CoV-2 infection or COVID-19 and, at this time, should also not be used to check for immunity. OTC - Over The Counter. The FDA said the tests. medical devices. Different tests are authorized to be used with different types of samples. 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. 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. Some tests have been granted an emergency use authorization (EUA) by the Food and Drug Administration (FDA), which is a designation used during public health emergencies like a global. 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. Venous blood samples are typically collected at a doctors office or clinic. 263a, that meet requirements to perform moderate complexity tests. Members of the public can submit questions about the templates to [email protected], or they can submit comments regarding the templates to the public docket established for the guidance Policy for Coronavirus Disease-2019 Tests (Revised). For information on tests that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results. The site is secure. Please discuss this issue on the article's talk page. 263a, that meet requirements to perform moderate complexity 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. there are additional considerations if administering a COVID-19 vaccine. M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. The FDA has updated expiration dates for those tests. Download it here. The revised Letter of Authorization establishes one additional Condition of Authorization and also eliminates one Condition of Authorization that is no longer needed. During the discussion, Watters asked DeSantis to respond to Donald Trump's comments about him in recent weeks. The test is to be performed two times over three days (serial testing). Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing aliquots of transport 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 any individual and placed in individual vials containing transport media, including individuals without symptoms or other reasons to suspect COVID-19, when tested as part of a serial testing program including testing at least once per week. Travel requirements to enter the United States are changing, starting November 8, 2021. The .gov means its official.Federal government websites often end in .gov or .mil. This article's lead section may be too long for the length of the article. The impacts of flu, COVID-19, and respiratory syncytial virus have underscored the importance of having tests . 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. Please read the layout guide and lead section guidelines to ensure the section will still be inclusive of all essential details. Click here for a full list of FDA approved at-home COVID tests and their up-to-date expiration dates. Since the start of the pandemic, we authorized over 300 tests and collection kits, including: An official website of the United States government, : To see complete information on smaller screens, select the blue plus (+) button beside the test name. 263a, that meet requirements to perform moderate complexity tests. The announcement made Pfizer and BioNTech the first companies to develop and test a working vaccine for COVID-19. However, antibody test results are not reported on the state's dashboard anyway. 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. People without symptoms. 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 . 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. Covering Phoenix, Mesa, Glendale, Scottsdale, Gilbert, the valley . FDA Home. Some diagnostic tests use other samples such as mid-turbinate, nasopharyngeal, oropharyngeal, or saliva samples. Authorized devices in the table below are assigned the QKO product code. 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. 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,. 263a, that meet requirements to perform high complexity tests. COVID-19 testing plays a critical role in the fight against the virus. 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). Test developers interested in pursuing an EUA may submit a pre-EUA to begin discussions with the FDA or may submit an EUArequest to [email protected]. There are different types of COVID-19 tests diagnostic tests and antibody tests. 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. 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. This page provides information on types of COVID-19 Tests and Supplies for laboratory personnel. 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. An official website of the United States government, : As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). Quidel QuickVue At-Home OTC . dba MicroGen DX, Columbia University Laboratory of Personalized Genomic Medicine, BioFire Respiratory Panel 2.1 (RP2.1) - On March 17, 2021, FDA granted the first marketing authorization using the De Novo review pathway for the. 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. Requires a Cue Cartridge Reader (sold separately). HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi. 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. 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. Everything you need to know about the next launch and detailed coverage on space missions. 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. 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. databases. They had the sniffles, and with a grandparent set to visit he wanted to minimize the risk that they were infectious. Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests. The TGA has approved the following COVID-19 self-tests (home use tests) for supply in Australia from 1 November 2021. Fox News Channel's Jesse Watters interviewed DeSantis Tuesday evening to discuss his book as well as his plans moving forward. 263a, that meet requirements to perform high complexity tests. Everything you need to know about Florida's theme parks and the all-new Attractions Insider podcast! , 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. There's a new federal resource to get free FDA-authorized coronavirus test kits. The site is secure. 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. Developers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. For more information about how the expiration date is determined and why it may be extended, see the At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions. These include molecular tests,. Seagen back in M&A talks after Merck walked away: WSJ Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul FDA hands first emergency authorization to over-the-counter test for both COVID and flu Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio BioCryst hits another hurdle, delays . Diagnostic Covid tests fall into two buckets: molecular tests and antigen tests. In the table below, the "Expiration Date" column lists the shelf-life and where to find the expiration date for that test. Viral Mutation Revision Letter September 23, 2021. Diagnostics able to detect current, active infections are typically antigen- and molecular-based 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. Authorized at-home OTC tests are available without a prescription and are typically available online or at local stores. "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.". For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs. The Food and Drug Administration prohibited 65 manufacturers from selling masks for medical use. 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. There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. Alternate brand name: GoodToKnow COVID-19 Antigen Rapid Test, Alternate brand name: GoToKnow COVID-19 Antigen Rapid Test, Alternate brand name: QuickFinder COVID-19 Antigen Self Test. For more information about this, read our FDA Safety Communication. If you think you need a COVID-19 diagnostic test, you can find a community testing site in your state. 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. Blood samples are only used to test for antibodies and not to diagnose COVID-19. 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. Since August 9, 2022, the standard regimen has also been authorized for people aged <18 years under . People with symptoms that began within the last 7 days. In 1947, Salk accepted a professorship at the University of Pittsburgh School of . A few weeks ago, a ProPublica reporter decided to test his kids for COVID-19. 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. In this photo illustration, an at-home COVID-19 test by . The FDA will update this table as additional shelf-life extensions are authorized. Test attributes are listed in the "Attributes" column. 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, : 2023, Charter Communications, all rights reserved. It quickly pivoted to a health professionals-only test and then rereleased its kit to the public after the. To be on this list, a lab must meet 4 criteria: Lab has a valid California clinical laboratory license and a CLIA certificate. (TB), all tests and examinations for TB diagnosis should be pursued without delay, regardless of JYNNEOS . The site is secure. 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. COVID-19 Tests and Collection Kits Authorized by the FDA. These at-home OTC COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations). Walmart. 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). BinaxNOW, however,. 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. 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. COVID-19 Tests and Collection Kits Authorized by the FDA The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. UPDATE. 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. It's an antigen test that gives you results in. The standard regimen is the FDA-approved dosing regimen. SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. 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. 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. The table includes links to home use instructions for each test. Testing and other protective steps like wearing a mask and COVID-19 vaccination are important to stop the spread of COVID-19 infection. Online, if you click to . 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. Currently the FDA HAS NOT approved any at-home or self-test kits. Rapid tests detect protein. 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. Samples for antibody tests are typically collected by a doctor or other medical professional by taking blood from a finger stick or your vein. Individuals ages 14 and older . 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. People with symptoms that began within the last 6 days. This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. A molecular test detects the genetic material of SARS-CoV-2. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. 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 latest Arizona headlines, breaking news, in-depth investigations, politics, and local community stories that matter to you. There are two main types of viral tests: nucleic acid amplification tests (NAATs) and antigen tests. To see if the expiration date for your at-home OTC COVID-19 test has been extended, first find the row in the below table that matches the manufacturer and test name shown on the box label of your test. Learn More. 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.
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