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National Library of Medicine

Archive-It Partner Since: Mar, 2009

Organization Type: National Institutions

Organization URL: http://www.nlm.nih.gov/   

Description:

The National Library of Medicine (NLM), the world's largest medical library and a component of the National Institutes of Health, collects, preserves, and makes available to the public information about health, medicine, and the biomedical sciences. To continue fulfilling this mission, NLM is collecting and archiving related Web content, which also serves to document the histories of health and medicine. For questions about our web archiving program contact us at nlmwebcollecting@nlm.nih.gov.

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Title: Message from EDC President: Legislative Achievements for Eating Disorders in the time of COVID-19— the CARES Act and Beyond

URL: http://eatingdisorderscoalition.org.s208556.gridserver.com/couch/uploads/file/edc-president-message-on-covid19-cares-act-final.pdf

Collection: Global Health Events web archive

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Title: Letter To The Editor:You Can Help Us Keep School Open | Fort Scott Biz

URL: http://fortscott.biz/news/letter-to-the-editoryou-can-help-us-keep-school-open/

Collection: Global Health Events web archive

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Title: Letter to the Editor: Wearing masks makes sense - Hillsdale Collegian

URL: http://hillsdalecollegian.com/2020/10/letter-to-the-editor-wearing-masks-makes-sense/

Collection: Global Health Events web archive

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Title: Letter to the Editor: Vaccines, viruses and public health – Daily Bulldog

URL: http://www.dailybulldog.com/db/opinion/letter-to-the-editor-vaccines-viruses-and-public-health/comment-page-1/

Collection: Global Health Events web archive

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Title: Letter to the editor: Cordes has been a strong advocate for Addison-4 | Addison County Independent

URL: https://addisonindependent.com/opeds/letter-editor-cordes-has-been-strong-advocate-addison-4

Collection: Global Health Events web archive

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Title: Letter to Editor: A Year of Living with COVID-19 - by Community Contributor - Ark Valley Voice

URL: https://arkvalleyvoice.com/letter-to-editor-a-year-of-living-with-covid-19/

Collection: Global Health Events web archive

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Title: ASBA pleased to be part of coalition of advocacy groups challenging anti-mask mandate law - Arizona School Boards Association

URL: https://azsba.org/asba-pleased-to-be-part-of-coalition-of-advocacy-groups-challenging-anti-mask-mandate-law/

Collection: Global Health Events web archive

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Title: Letter to the editor: COVID-19 Vaccine: What they're not telling you | | billingsgazette.com

URL: https://billingsgazette.com/letter-to-the-editor-covid-19-vaccine-what-theyre-not-telling-you/article_67d2e7b1-3a03-50f1-aa16-aba59dd83ef1.html

Collection: Global Health Events web archive

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Title: Letter to the editor: COVID-19 relief flawed | Letters to the Editor | billingsgazette.com

URL: https://billingsgazette.com/opinion/letters/letter-to-the-editor-covid-19-relief-flawed/article_8054853f-0f81-5782-b9e6-2ffbbdc7164a.html

Collection: Global Health Events web archive

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Title: Letter to the editor: Weigh costs of COVID precautions | Letters to the Editor | billingsgazette.com

URL: https://billingsgazette.com/opinion/letters/letter-to-the-editor-weigh-costs-of-covid-precautions/article_ef184569-7aae-586b-be6e-da98a016f76f.html

Collection: Global Health Events web archive

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Title: Campus update on Monkeypox | Inside UCR

URL: https://insideucr.ucr.edu/announcements/2022/08/03/campus-update-monkeypox

Collection: Global Health Events web archive

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Title: Letter to the Editor: There are no easy choices in the time of a pandemic

URL: https://ithacavoice.com/2020/09/letter-to-the-editor-there-are-no-easy-choices-in-the-time-of-a-pandemic/

Collection: Global Health Events web archive

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Title: Letter to the editor: A veterinarian explains COVID-19 protocols for pet clinics

URL: https://myedmondsnews.com/2020/11/letter-to-the-editor-a-veterinarian-explains-covid-19-protocols-for-pet-clinics/

Collection: Global Health Events web archive

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Title: UEA Letter to Utah State Board of Education on School Health Requirements 9-18-20

URL: https://myuea.org/sites/utahedu/Uploads/files/Politics/2020%20Under%20the%20Dome/UEA%20Letter%20to%20USBE%20on%20School%20Health%20Requirements%209-18-20.pdf

Collection: Global Health Events web archive

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Title: Rapid Expert Consultation on SARS-CoV-2 Surface Stability and Incubation for the COVID-19 Pandemic (March 15, 2020) | The National Academies Press

URL: https://nap.nationalacademies.org/catalog/25751/rapid-expert-consultation-on-sars-cov-2-surface-stability-and-incubation-for-the-covid-19-pandemic-march-15-2020

Collection: Global Health Events web archive

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Title: Letters to the Editor: If the FDA rushes a COVID-19 vaccine, Trump should be the first to take it

URL: https://news.yahoo.com/letters-editor-fda-rushes-covid-100050213.html

Collection: Global Health Events web archive

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URL: https://nvf.org/the-nvfs-responds-to-covid-19/

Collection: Global Health Events web archive

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Title: Liveblog: Coronavirus Information for Palau

URL: https://palaudiveadventures.com/coronavirus-palau/

Collection: Global Health Events web archive

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Title: Letter to the editor: Why are my kids still wearing masks at school? - Paso Robles Daily News

URL: https://pasoroblesdailynews.com/letter-to-the-editor-why-are-my-kids-still-wearing-masks-at-school/138854/

Collection: Global Health Events web archive

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Title: Letter To The Editor: Bob Duff Puts Children & Our Health First | Norwalk, CT Patch

URL: https://patch.com/connecticut/norwalk/letter-editor-bob-duff-puts-children-our-health-first

Collection: Global Health Events web archive

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Title: World Leader 2 Year Letter - People's Vaccine People's Vaccine

URL: https://peoplesvaccine.org/resources/media/world-leader-2-year-letter/

Collection: Global Health Events web archive

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Title: Open Letter: Former Heads of State and Nobel Laureates Call on President Biden To Waive Intellectual Property Rules for COVID Vaccines | by People's Vaccine Alliance | Medium

URL: https://peoplesvaccinealliance.medium.com/open-letter-former-heads-of-state-and-nobel-laureates-call-on-president-biden-to-waive-e0589edd5704

Collection: Global Health Events web archive

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Title: Letter to the editor: We need a vaccine to recover fully | Letters | poststar.com

URL: https://poststar.com/opinion/letters/letter-to-the-editor-we-need-a-vaccine-to-recover-fully/article_d4c3ace5-d29a-54be-a833-d9898338da38.html

Collection: Global Health Events web archive

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Title: Letter to the Editor, June 14, 2021: Despite COVID-19 fears, we have survived much | Letters | richmond.com

URL: https://richmond.com/opinion/letters/letter-to-the-editor-june-14-2021-despite-covid-19-fears-we-have-survived-much/article_e65a386a-f16b-58be-adf8-17597da3a8c3.html

Collection: Global Health Events web archive

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Title: Letter from Amazon to President Biden

URL: https://s3.documentcloud.org/documents/20460436/president-biden-letter_1-20-2021-final.pdf

Collection: Global Health Events web archive

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Title: Investigate the origins of COVID-19

URL: https://science.sciencemag.org/content/372/6543/694.1

Collection: Global Health Events web archive

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Title: Letter to the Editor | Facing COVID, the US Still Must Rise to the Occasion | The South Pasadenan | South Pasadena News

URL: https://southpasadenan.com/letter-to-the-editor-facing-covid-the-us-still-must-rise-to-the-occasion/

Collection: Global Health Events web archive

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Title: An Open Letter to Spotify – An Open Letter to Spotify

URL: https://spotifyopenletter.wordpress.com/2022/01/10/an-open-letter-to-spotify/

Collection: Global Health Events web archive

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Title: Letter to the Editor: Remove the mask mandate at TU

URL: https://thetowerlight.com/letter-to-the-editor-remove-the-mask-mandate-at-tu/

Collection: Global Health Events web archive

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Title: Letter to the editor: Covid-19 restrictions must stop

URL: https://triblive.com/opinion/letter-to-the-editor-covid-19-restrictions-must-stop/

Collection: Global Health Events web archive

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Title: Letter to the editor: Covid-19 testing useless without follow-up

URL: https://triblive.com/opinion/letter-to-the-editor-covid-19-testing-useless-without-follow-up/

Collection: Global Health Events web archive

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Title: Letter to the editor: Polio was conquered; covid-19 will be, too

URL: https://triblive.com/opinion/letter-to-the-editor-polio-was-conquered-covid-19-will-be-too/

Collection: Global Health Events web archive

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Title: Letter to the Editor: Finding gratitude after surviving COVID-19 | Letters to the Editor | tulsaworld.com

URL: https://tulsaworld.com/opinion/letters/letter-to-the-editor-finding-gratitude-after-surviving-covid-19/article_5f095e0c-294e-11eb-891d-0b04543f0d0d.html

Collection: Global Health Events web archive

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Title: Campus Update on Monkeypox | Coronavirus Information Hub | UCI

URL: https://uci.edu/coronavirus/messages/220802-update-on-monkeypox.php

Collection: Global Health Events web archive

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Title: Letter to the editor: 11-year-old’s view of COVID » Albuquerque Journal

URL: https://www.abqjournal.com/1521652/letter-to-the-editor-11-year-olds-view-of-covid.html

Collection: Global Health Events web archive

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Title: Hospitals, Physicians, Nurses Urge HHS to Address COVID-19 Disparities | AHA

URL: https://www.aha.org/lettercomment/2020-04-16-hospitals-physicians-nurses-urge-hhs-address-covid-19-disparities/

Collection: Global Health Events web archive

Description: "Hospitals, Physicians, Nurses Urge HHS to Address COVID-19 Disparities" -- open letter to Secretary Azar.

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Title: Achieving A Fair and Effective COVID-19 Response: An Open Letter to Vice-President Mike Pence, and Other Federal, State and Local Leaders from Public Health and Legal Experts in the United States

URL: https://www.amnestyusa.org/wp-content/uploads/2020/03/Full-letter.pdf

Collection: Global Health Events web archive

Description: Document titled, "Achieving A Fair and Effective COVID-19 Response: An Open Letter to Vice-President Mike Pence, and

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Title: Letter to the Editor: COVID-19 nonsense | Opinion | bakersfield.com

URL: https://www.bakersfield.com/opinion/letter-to-the-editor-covid-19-nonsense/article_e21c745c-6673-11eb-9ad5-0b367c7631fa.html

Collection: Global Health Events web archive

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Title: Letter to the Editor: Many people to thank for COVID vaccines | Letters to the Editor | beacononlinenews.com

URL: https://www.beacononlinenews.com/opinion/letters_to_editor/letter-to-the-editor-many-people-to-thank-for-covid-vaccines/article_aa9d3482-396c-11eb-9672-4febb7fe1049.html

Collection: Global Health Events web archive

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Title: LETTER TO THE EDITOR: Please mask up | Bemidji Pioneer

URL: https://www.bemidjipioneer.com/opinion/letters/6662444-LETTER-TO-THE-EDITOR-Please-mask-up

Collection: Global Health Events web archive

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Title: Information for Healthcare Facilities Concerning 2019 Novel Coronavirus Illness (2019-nCoV)

URL: https://www.cms.gov/files/document/qso-20-09-all.pdf

Collection: Global Health Events web archive

Description: This three-page memorandum provides information from the Centers for Disease Control and Prevention (CDC) regarding patients with possible 2019 novel coronavirus (COVID-19) illness. The Centers for Medicare and Medicaid Services strongly urges the review of CDC's guidance, and encourages healthcare facilities to review their own infection prevention and control policies and practices to prevent the spread of infection.

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Title: Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Use in CDC Qualified Laboratories

URL: https://www.cms.gov/files/document/qso-20-10-clia.pdf

Collection: Global Health Events web archive

Description: This three-page memorandum provides guidance to surveyors in regard to the authorization for emergency use of the Centers for Disease Control and Prevention (CDC)'s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel assay. Upon receipt of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and corresponding manufacturer's instructions (MI), CDC-qualified laboratories will verify assay performance specifications in their laboratory per the manufacturer's instructions.

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Title: My Turn: An open letter to COVID-19

URL: https://www.concordmonitor.com/A-warning-for-COVID-19-34292874/

Collection: Global Health Events web archive

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Title: Information for our community regarding COVID-19 – Update – Disabled Veterans National Foundation

URL: https://www.dvnf.org/covid-19-update/

Collection: Global Health Events web archive

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Title: Information for our community regarding COVID-19 – Disabled Veterans National Foundation

URL: https://www.dvnf.org/covid-19/

Collection: Global Health Events web archive

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Title: Letter from the Editor: Working Through the COVID Pandemic Is the Hardest Thing I’ve Ever Done - ENTtoday

URL: https://www.enttoday.org/article/letter-from-the-editor-working-through-the-covid-pandemic-is-the-hardest-thing-ive-ever-done/

Collection: Global Health Events web archive

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Title: NIOSH-Approved Disposable Filtering Facepiece Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA (Emergency Use Authorization)

URL: https://www.fda.gov/media/135763/download

Collection: Global Health Events web archive

Description: This nine-page letter, reissued multiple times, authorizes certain National Institute for Occupational Safety and Health (NIOSH)-approved respirators not currently regulated by the Food and Drug Administration (FDA) to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system. When properly fitted, respirators, such as N95s, can filter more airborne particles than face masks, which is important during an outbreak of a respiratory disease like COVID-19.

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Title: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators - FDA Authorization Letter, Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators - FDA Authorization Letter

URL: https://www.fda.gov/media/136403/download

Collection: Global Health Events web archive

Description: This 10-page Letter of Authorization was updated on June 6, 2020, with five revisions regarding the emergency use of the authorized respirators, as described in the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) of this letter for use in healthcare settings by healthcare providers when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during filtering facepiece respirator shortages resulting from the COVID-19 outbreak.

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Title: Letter of Authorization: Yale New Haven Hospital, Clinical Virology Laboratory, SARS-CoV-2 PCR Test

URL: https://www.fda.gov/media/136601/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Yale New Haven Hospital SARS-CoV-2 PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter of Authorization: SARS-CoV-2 RT-PCR Test; Infectious Disease Diagnostics Laboratory, Department of Pathology and Laboratory Medicine at the Children's Hospital of Philadelphia

URL: https://www.fda.gov/media/136657/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Infectious Disease Diagnostics Laboratory, Department of Pathology and Laboratory Medicine at the Children's Hospital of Philadelphia SARS-CoV-2 PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter of Authorization: SARS-Cov-2 Assay; Northwestern Diagnostic Molecular Laboratory

URL: https://www.fda.gov/media/136658/download

Collection: Global Health Events web archive

Description: This two-page letter authorizes the emergency use of the Northwestern Diagnostic Molecular Laboratory SARS-Cov-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China - FDA Authorization Letter

URL: https://www.fda.gov/media/136664/download

Collection: Global Health Events web archive

Description: This nine-page letter, revised on June 6, 2020, updates the April 3, 2020, Emergency Use Authorization for certain product classifications for imported disposable filtering facepiece respirators that are manufactured in China and not approved by the Centers for Disease Control and Prevention's National Institute of Occupational Safety and Health (NIOSH). The Scope of Authorization was revised such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.

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Title: Letter of Authorization: Viracor SARS-CoV-2 Assay

URL: https://www.fda.gov/media/136739/download

Collection: Global Health Events web archive

Description: This one-page document authorizes the emergency use of the Viracor SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: SARS-CoV-2 RT-PCR Assay FDA Authorization Letter

URL: https://www.fda.gov/media/136817/download

Collection: Global Health Events web archive

Description: This one-page document authorizes the emergency use of the Stanford SARS-CoV-2 PCR Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: COVID-19 Emergency Use Authorization: Manufacturers of Face Shields; Health Care Personnel; Hospital Purchasing Departments and Distributors; and Any Other Stakeholders

URL: https://www.fda.gov/media/136842/download

Collection: Global Health Events web archive

Description: The U.S. Food and Drug Administration (FDA) has issued this six-page Emergency Use Authorization (EUA) in response to concerns relating to insufficient supply and availability of face shields for use by healthcare personnel as personal protective equipment (PPE) in healthcare settings in accordance with Centers for Disease Control and Prevention recommendations to cover the front and sides of the face and provide barrier protection during the coronavirus disease 2019 (COVID-19) pandemic.

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Title: Letter of Authorization: Orig3n 2019 Novel Coronavirus (COVID-19) Test

URL: https://www.fda.gov/media/136874/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Orig3n 2019 Novel Coronavirus (COVID-19) Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter of Authorization: SDI SARS-CoV-2 Assay, Specialty Diagnostic (SDI) Laboratories

URL: https://www.fda.gov/media/136878/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the SDI SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter of Authorization: UNC Health SARS-CoV-2 Real-Time RT-PCR Test

URL: https://www.fda.gov/media/136879/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the UNC Health SARS-CoV-2 Real-Time RT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter of Authorization: SARS-CoV-2 Assay, Integrity Laboratories

URL: https://www.fda.gov/media/136941/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Integrity Laboratories SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter of Authorization: CirrusDx SARS-CoV-2 Assay

URL: https://www.fda.gov/media/137035/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the CirrusDx SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter of Authorization: CDI Enhanced COVID-19 Test, HUMC Molecular Pathology Laboratory

URL: https://www.fda.gov/media/137037/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the CDI Enhanced COVID-19 Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: FDA Authorization Letter

URL: https://www.fda.gov/media/137121/download

Collection: Global Health Events web archive

Description: This seven-page document, updated on April 24, 2020, details how the emergency use of face masks by the general public and healthcare workers, in accordance with Centers for Disease Control and Prevention recommendations, as personal protective equipment to help prevent spread of the virus during the COVID-19 pandemic meets the criteria for issuance of an Emergency Use Authorization.

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Title: Letter of Authorization: SARS-CoV-2 PCR Test, Diatherix Eurofins Laboratory

URL: https://www.fda.gov/media/137256/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Diatherix SARS-CoV-2 PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: COVID-19 Key FDA Authorization Letter

URL: https://www.fda.gov/media/137369/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the COVID-19 Key Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: UDX SARS-CoV-2 Molecular Assay FDA Authorization Letter

URL: https://www.fda.gov/media/137371/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the UDX SARS-CoV-2 Molecular Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: SARS-CoV-2 Assay FDA Authorization Letter

URL: https://www.fda.gov/media/137373/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the AIT Laboratories SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200360 Trade/Device Name: SARS-CoV-2 Assay Laboratory: Nationwide Children’s Hospital

URL: https://www.fda.gov/media/137424/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Nationwide Children's Hospital SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200171 Trade/Device Name: SAR-Co-V-2 Assay Laboratory: Biocerna

URL: https://www.fda.gov/media/137451/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Biocerna SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200123 Trade/Device Name: Altru Dx SARS-CoV-2 Assay Laboratory: Altru Diagnostics, Inc.

URL: https://www.fda.gov/media/137545/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Altru Dx SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: EUA 046 Gilead Remdesivir LOA Outpatients (01212022)

URL: https://www.fda.gov/media/137564/download

Collection: Global Health Events web archive

Description: The Food and Drug Administration (FDA) updated this Emergency Use Authorization (EUA) on October 1, 2020, to permit the emergency use of the unapproved product remdesivir for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and children hospitalized with severe disease. The FDA approved remdesivir for the treatment of COVID-19 requiring hospitalization on October 22, 2020.

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Title: Letter Re: EUA200338 Trade/Device Name: UTHSC/UCH SARS-CoV-2-RT-PCR Assay Laboratory: UTMG Pathology Laboratory

URL: https://www.fda.gov/media/137654/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the UTHSC/UCH SARS-CoV-2-RT-PCR Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200025 Trade/Device Name: Biocollections Worldwide SARS-Co-V-2 Assay Laboratory: Biocollections Worldwide, Inc

URL: https://www.fda.gov/media/137896/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Biocollections Worldwide SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200510 Trade/Device Name: Triplex CII-SARS-CoV-2 rRT-PCR Test Laboratory: Columbia University Laboratory of Personalized Genomic Medicine

URL: https://www.fda.gov/media/137982/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Triplex CII-SARS-CoV-2 rRT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200013 Trade/Device Name: One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test Laboratory: One Health Laboratories, LLC

URL: https://www.fda.gov/media/138062/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Everlywell COVID-19 Test Home Collection Kit - Letter of Authorization

URL: https://www.fda.gov/media/138144/download

Collection: Global Health Events web archive

Description: This seven-page letter details the Emergency Use Authorization for the Everlywell COVID-19 Test Home Collection Kit, which is intended to facilitate self-collection of nasal swab specimens at home by individuals when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.

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Title: Color SARS-CoV-2 RT-LAMP Diagnostic Assay - Letter of Authorization

URL: https://www.fda.gov/media/138248/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Color SARS-CoV-2 LAMP Diagnostic Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Gowns and Other Apparel - Letter of Authorization

URL: https://www.fda.gov/media/138326/download

Collection: Global Health Events web archive

Description: This eight-page letter of authorization details the Emergency Use Authorization (EUA) issued in response to concerns relating to insufficient supply and availability of gowns and other apparel for use by healthcare personnel (HCP) as personal protective equipment (PPE) for use in healthcare settings in accordance with Centers for Disease Control and Prevention (CDC) recommendations to protect both HCP and patients from the transfer of SARS-CoV-2, which causes COVID-19, in low or minimal risk level situations to prevent the spread of COVID-19.

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Title: SARS-CoV-2 (N gene detection) Test - Letter of Authorization

URL: https://www.fda.gov/media/138327/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Exact Sciences SARS-CoV-2 (N gene detection) test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Avera Institute for Human Genetics SARS-CoV-2 Assay - Letter Granting Inclusion Under EUA

URL: https://www.fda.gov/media/138331/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Avera Institute for Human Genetics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200425 Trade/Device Name: CSI SARS-CoV-2 RT PCR Test Laboratory: CSI Laboratories

URL: https://www.fda.gov/media/138529/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the CSI SARS-CoV-2 RT PCR test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: : EUA200306 Trade/Device Name: Warrior Diagnostics SARS-CoV-2 Assay - FDA Authorization Letter, : EUA200306 Trade/Device Name: Warrior Diagnostics SARS-CoV-2 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/138791/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Warrior Diagnostics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: EUA200187 Trade/Device Name: Cormeum SARS-CoV-2 Assay - FDA Authorization Letter, EUA200187 Trade/Device Name: Cormeum SARS-CoV-2 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/138933/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Corneum SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: FDA Authorization Letter

URL: https://www.fda.gov/media/138945/download

Collection: Global Health Events web archive

Description: This 15-page document provides a memorandum explaining the basis for revocation of the Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate, effective June 15, 2020.

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Title: Revocation of EUA200179 - FDA Authorization Letter

URL: https://www.fda.gov/media/139109/download

Collection: Global Health Events web archive

Description: This three-page letter, issued on June 16, 2020, is notification of the revocation of the Emergency Use Authorization for the DPP COVID-19 IgM/IgG System, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020.

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Title: OSUWMC COVID-19 RT-PCR test - FDA Authorization Letter

URL: https://www.fda.gov/media/139285/download

Collection: Global Health Events web archive

Description: This seven-page letter details the Emergency Use Authorization (EUA) for the OSUWMC (Ohio State University Wexner Medical Center) COVID-19 RT-PCR test for qualitative detection of nucleic acid from SARS-CoV-2 in nasal, oropharyngeal (OP), and nasopharyngeal (NP) swab specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: Omni COVID-19 Assay by RT-PCR - FA Authorization Letter

URL: https://www.fda.gov/media/139289/download

Collection: Global Health Events web archive

Description: This seven-page letter details the Emergency Use Authorization (EUA) for the Omni COVID-19 Assay by RT-PCR for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: FDA Authorization Letter

URL: https://www.fda.gov/media/139391/download

Collection: Global Health Events web archive

Description: This seven-page letter, updated on June 22, 2020, authorizes the emergency use of the COVID-19 Airway Management Isolation Chamber. This device is authorized for use by healthcare providers (HCP) as an extra layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates during transport of patients, at the time of definitive airway management, or when performing medical procedures on such patients during the COVID-19 pandemic.

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Title: FRL SARS CoV-2 Test - FDA Authorization Letter

URL: https://www.fda.gov/media/139439/download

Collection: Global Health Events web archive

Description: This seven-page letter details the Emergency Use Authorization (EUA) for the FRL SARS CoV-2 Test for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: HealthQuest Esoterics TaqPath SARS-CoV-2 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/139449/download

Collection: Global Health Events web archive

Description: This seven-page letter details the Emergency Use Authorization (EUA) for the HealthQuest Esoterics TaqPath SARS-CoV-2 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: DSL COVID-19 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/139513/download

Collection: Global Health Events web archive

Description: This seven-page letter details the Emergency Use Authorization (EUA) for the DSL COVID-19 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swabs) and bronchioalveolarlavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: Inform Diagnostics SARS-CoV-2 RT-PCR Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/139569/download

Collection: Global Health Events web archive

Description: This seven-page letter details the Emergency Use Authorization (EUA) for the Inform Diagnostics SARS-CoV-2 RT-PCR Assay for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: Kroger Health COVID-19 Test Home Collection Kit - FDA Authorization Letter

URL: https://www.fda.gov/media/139681/download

Collection: Global Health Events web archive

Description: This seven-page letter authorizes the use of this home collection kit by individuals to self-collect nasal swab specimens at home, video-observed by a heathcare provider, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-CoV-2 RNA that are indicated for use with the Kroger Health COVID-19 Test Home Collection Kit.

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Title: UCSD RC SARS-CoV-2 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/140714/download

Collection: Global Health Events web archive

Description: This eight-page letter details the Emergency Use Authorization (EUA) for the UCSD RC SARS-CoV-2 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swab specimens) collected from individuals suspected of COVID-19 by their healthcare provider. This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples.

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Title: EmpowerDX COVID-19 Home Collection Kit DTC - Letter of Authorization

URL: https://www.fda.gov/media/143063/download

Collection: Global Health Events web archive

Description: This letter authorizes the emergency use of the EmpowerDX At-Home COVID-19 PCR Test Kit for use by individuals to self-collect nasal swabs at home, when determined by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-CoV-2 RNA that are indicated for use with the EmpowerDX At-Home COVID-19 PCR Test Kit.

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Title: binx health At-Home Nasal Swab COVID-19 Sample Collection Kit - Letter of Authorization

URL: https://www.fda.gov/media/143183/download

Collection: Global Health Events web archive

Description: This letter authorizes the emergency use of the binx health At-Home Nasal Swab COVID-19 Sample Collection Kit. The kit is for use by individuals for self-collection of nasal swab specimens at home, when determined by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire and for use only with an in vitro diagnostic (IVD) molecular test for the detection of SARS-CoV-2 RNA that is indicated for use with the binx health At-Home Nasal Swab COVID-19 Sample Collection Kit.

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Title: Letter to Eli Lilly & Company from the US Food & Drug Administration Re: Emergency Use Authorization 090

URL: https://www.fda.gov/media/143602/download

Collection: Global Health Events web archive

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Title: Regeneron Letter of Authorization, February 25, 2021

URL: https://www.fda.gov/media/145610/download

Collection: Global Health Events web archive

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