Title: 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic

Collection: Global Health Events web archive

Description: This web page provides answers to frequently asked questions for entities who use 3D printing of devices, accessories, components, and/or parts during the COVID-19 emergency. The Food and Drug Administration recognizes that the public may seek to use 3D printing to assist in meeting demand for certain products during the COVID-19 pandemic.

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Title: Addressing New Variants: A Federal Perspective On The Covid-19 Response - 01/11/2022 | FDA

URL: https://www.fda.gov/news-events/congressional-testimony/addressing-new-variants-federal-perspective-covid-19-response-01112022

Collection: Global Health Events web archive

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Title: Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19

Collection: Global Health Events web archive

Description: This web page answers questions about adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of COVID-19-related guidance documents, and points out a number of adverse event reporting-related resources.

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Title: Announcing the Winner of the 2016 FDA Naloxone App Competition

URL: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm533711.htm

Collection: Opioid Epidemic web archive

Description: Press release published on the U.S. Food and Drug Administration (FDA) Website announcing the winner of the 2016 FDA Naloxone app competition. The winning app, OD Help, was developed as a simple, easy-to-use mobile app that connects potential opioid overdose victims with a crowd-sourced network of naloxone carriers.

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Title: Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments | FDA

URL: https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments/

Collection: Global Health Events web archive

Description: Website from U.S. Food and Drug Administration regarding fraudulent COVID-19 tests, vaccines and treatments

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Title: Brote de la enfermedad del Ébola en África Occidental de 2014

URL: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/ucm411643.htm

Collection: Global Health Events web archive

Description: Page on the US Food and Drug Administration (USDA) website featuring the most recent updates on the Ebola response at the Food and Drug Administration (FDA) in Spanish. The FDA is working to expedite the development and availability of medical products, including treatments, vaccines, diagnostic tests, and personal protective equipment, that may help to end the Ebola epidemic in West Africa.

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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: Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-policies-guide-medical-product-developers-addressing-virus/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic

Collection: Global Health Events web archive

Description: This web page provides guidance for immediate implementation to address the urgent and immediate need for blood and blood components during the COVID-19 pandemic. The FDA has concluded that current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply.

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Title: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab/

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) Update: October 26, 2021 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-october-26-2021

Collection: Global Health Events web archive

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Title: Coronavirus (COVID-19) and Medical Devices | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices

Collection: Global Health Events web archive

Description: Website from the U.S. Food and Drug Administration regarding COVID-19 and medical devices, includes information about in vitro diagnostic tests, masks and respirators, PPE, ventilators, and other medical devices.

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Title: Coronavirus Disease 2019 (COVID-19) Resources for Patients | FDA

URL: https://www.fda.gov/patients/coronavirus-disease-2019-covid-19-resources-patients/

Collection: Global Health Events web archive

Description: US Food and Drug Administration web page of coronavirus resources for patients. Includes information on hand sanitizers, testing and treatment options, donating blood and plasma, fake products, medical product shortages, clinical trials, food safety, and the expanded access program.

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Title: Coronavirus Disease 2019 (COVID-19) | FDA

URL: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19/

Collection: Global Health Events web archive

Description: Website for COVID-19 related resources produced and curated by the U.S. Food & Drug Administration (FDA).

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Title: Coronavirus Testing Basics | FDA

URL: https://www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics/

Collection: Global Health Events web archive

Description: Website from the US Food and Drug Administration, "Coronavirus Disease 2019 Testing Basics", with information on COVID-19 testing and other resources.

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Title: Donate COVID-19 Plasma | FDA

URL: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/donate-covid-19-plasma

Collection: Global Health Events web archive

Description: Website from the Food and Drug Administration on donating COVID-19 plasma. Includes a video with information on donation, frequently asked questions, and other resources.

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Title: Emergency Use Authorizations | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations/

Collection: Global Health Events web archive

Description: Page on the US Food and Drug Administration (USDA) website featuring Emergency Use Authorizations (EUA) for the Coronavirus Disease 2019 (COVID-19), Zika Virus, 2014 Ebola Virus outbreak, and other global pandemics.

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Title: Enfermedad del Coronavirus (COVID-19) | FDA

URL: https://www.fda.gov/about-fda/fda-en-espanol/enfermedad-del-coronavirus-covid-19

Collection: Global Health Events web archive

Description: Website from U.S. Food and Drug Administration, page in Spanish. Information regarding vaccines, treatments, health fraud, and more

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Title: Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public

Collection: Global Health Events web archive

Description: This eight-page guidance provides a policy to help expand the availability of clinical electronic thermometers to address the COVID-19 public health emergency. These devices include both contact and non-contact clinical electronic thermometers.

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Title: Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency

URL: https://www.fda.gov/media/136540/download

Collection: Global Health Events web archive

Description: The Food and Drug Administration (FDA) has issued an immediately-in-effect guidance to help expand the availability of surgical apparel for healthcare professionals, including gowns (togas), hoods, and surgeon's and patient examination gloves during this COVID-19 public health emergency. FDA believes the policy set forth in this 15-page guidance may help address the urgent public health concerns caused by shortages of such products by taking a risk-based approach and clarifying the policies that FDA intends to apply to gowns and other apparel, including these products' associated indications and claims.

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Title: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-infusion-pumps-and-accessories-during-coronavirus-disease-2019-covid-19-public

Collection: Global Health Events web archive

Description: This 16-page guidance provides a policy to help expand the availability and remote capabilities of infusion pumps and their accessories for health care professionals during the COVID-19 pandemic. These products are used to treat patients who require continuous infusion therapy during the COVID-19 public health emergency.

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Title: Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-remote-ophthalmic-assessment-and-monitoring-devices-during-coronavirus-disease

Collection: Global Health Events web archive

Description: This 11-page guidance provides a policy to help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 during the COVID-19 pandemic.

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Title: Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-sterilizers-disinfectant-devices-and-air-purifiers-during-coronavirus-disease

Collection: Global Health Events web archive

Description: The Food and Drug Administration (FDA) has issued this immediately-in-effect 14-page guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers. The devices include those intended to make devices sterile, kill pathogens or other microorganisms, and kill pathogens or microorganisms in the air. This policy reflects FDA's commitment to ease burdens on healthcare providers and facilities as they face COVID-19.

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Title: Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

URL: https://www.fda.gov/media/137079/download

Collection: Global Health Events web archive

Description: This 10-page guidance has been issued to provide a policy to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the COVID-19 public health emergency.

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Title: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus

Collection: Global Health Events web archive

Description: The Food and Drug Administration has issued this 14-page guidance to provide a policy to help expand the availability of ventilators, as well as other respiratory devices and their accessories, during the COVID-19 pandemic. It lists the devices and accessories that the guidance applies to.

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Title: FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19 | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-related-covid-19

Collection: Global Health Events web archive

Description: This web page provides answers to frequently asked questions about Emergency Use Authorizations (EUAs) and medical devices during the COVID-19 pandemic.

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Title: FAQs on Testing for SARS-CoV-2 | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2

Collection: Global Health Events web archive

Description: This web page, updated regularly, provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2.

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Title: FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

Collection: Global Health Events web archive

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Title: FDA Briefing Document - Vaccines and Related Biological Products Advisory Committee Meeting

URL: https://www.fda.gov/media/159452/download

Collection: Global Health Events web archive

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Title: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic/

Collection: Global Health Events web archive

Description: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency", dated March 2020

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Title: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory

Collection: Global Health Events web archive

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Title: FDA Medical Countermeasures Initiative (@FDA_MCMi) | Twitter

URL: https://twitter.com/FDA_MCMi/

Collection: Global Health Events web archive

Description: Twitter account page for the Food and Drug Administration (FDA) Medical Countermeasures Initiative (MCMi).

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Title: FDA Protects Patients and Consumers from Fraud During COVID-19 | FDA

URL: https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19/

Collection: Global Health Events web archive

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Title: FDA Research, Policy, and Workshops on Women in Clinical Trials | FDA

URL: https://www.fda.gov/science-research/womens-health-research/fda-research-policy-and-workshops-women-clinical-trials/

Collection: Women's Health web archive

Description: Website from U.S. Food and Drug Administration regarding FDA research, policy, and workshops on Women in Clinical Trials.

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Title: FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines

Collection: Global Health Events web archive

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Title: FDA and CDC Virtual Press Conference: Johnson & Johnson COVID-19 Vaccine - 4/23/2021 - YouTube

URL: https://www.youtube.com/watch?v=Nf_OuB1rBi0

Collection: Global Health Events web archive

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Title: FDA approves first buprenorphine implant for treatment of opioid dependence | FDA

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm

Collection: Opioid Epidemic web archive

Description: Press release published on the U.S. Food and Drug Administration (FDA) Website on May 26, 2016. The Press release discusses the FDA approval of the first buprenorphine implant (Probuphine) for treatment of opioid dependence.

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Title: FDA warns consumers about fraudulent Ebola treatment products

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410086.htm

Collection: Global Health Events web archive

Description: Press release titled, "FDA warns consumers about fraudulent Ebola treatment protocols," published on the Food and Drug Administration (FDA) website on August 14, 2014. The statement provides factual information regarding Ebola treatments.

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Title: Fact Sheet for Health Care Professionals: Interpreting CDC Novel Coronavirus 2012 Real-time RT-PCR Assay Test Results | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/fact-sheet-health-care-professionals-interpreting-cdc-novel-coronavirus-2012-real-time-rt-pcr-assay

Collection: Global Health Events web archive

Description: This resource provides information about the Food and Drug Administration (FDA)'s issuance of an Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Novel Coronavirus 2012 Real-time RT-PCR Assay to test for the presumptive presence of Middle East respiratory syndrome coronavirus (MERS-CoV) in the following clinical specimens: upper respiratory specimens, such as nasopharyngeal swabs and oropharyngeal swabs; lower respiratory specimens, such as bronchoalveolar lavage, bronchial wash, tracheal aspirate, and sputum; serum; and stool.

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Title: Fact Sheet for Healthcare Personnel: ASP STERRAD Sterilization System for Decontaminating Compatible N95 Respirators

URL: https://www.fda.gov/media/136881/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare personnel of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators during the COVID-19 pandemic. These compatible N95 respirators have been decontaminated using one of three Advanced Sterilization Products STERRAD Sterilization Systems, using the STERRAD Sterilization Cycles for N95 respirator decontamination: STERRAD 100S Cycle, STERRADNX Standard Cycle, or STERRAD100NX Express Cycle.

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Title: Fact Sheet for Healthcare Personnel: Battelle Decontamination System for Decontaminating Compatible N95 Respirators

URL: https://www.fda.gov/media/136530/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare personnel of the significant known and potential risks and benefits of the emergency use of decontaminated N95 or N95-equivalent respirators. These compatible N95 or N95-equivalent respirators have been decontaminated using the Battelle CCDS Critical Care Decontamination Systemâ„¢. The document is for healthcare personnel who have been given a decontaminated N95 or N95- equivalent respirator that has been decontaminated using a decontamination system for reuse by healthcare personnel in a healthcare setting to help prevent healthcare personnel exposure to pathogenic biologic airborne particulates during the COVID-19 pandemic.

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Title: Fact Sheet for Healthcare Personnel: STERIS Sterilization Systems for Decontaminating Compatible N95 Respirators

URL: https://www.fda.gov/media/136846/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare personnel of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators during the COVID-19 pandemic. These compatible N95 respirators have been decontaminated using the STERIS N95 Respirator Decontamination Cycle (Non-Lumen Cycle) in STERIS V-PRO 1 Plus, V-PRO maX, and V-PRO maX2 Sterilizers.

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Title: Fact Sheet for Healthcare Personnel: Sterilucent Sterilization System for Decontaminating Compatible N95 Respirators

URL: https://www.fda.gov/media/137170/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare personnel of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators. These compatible N95 respirators have been decontaminated using the Sterilucent HC 80TT Vaporized Hydrogen Peroxide (VHP) Sterilizer. Decontaminated N95 respirators that have been decontaminated using the Sterilucent Sterilization System are authorized for single-user reuse by healthcare personnel in a healthcare setting during the COVID-19 pandemic.

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Title: Fact Sheet for Healthcare Providers

URL: https://www.fda.gov/media/134920/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)

URL: https://www.fda.gov/media/146304/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: ARIES® SARS-CoV-2 Assay - Luminex Corporation

URL: https://www.fda.gov/media/136692/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ARIES® SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The ARIES® SARS-CoV-2 Assay is authorized for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Abbott RealTime SARS-CoV-2 Assay; Abbott Molecular, Inc.

URL: https://www.fda.gov/media/136256/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Accula SARS-Cov-2 Test - Mesa Biotech Inc.

URL: https://www.fda.gov/media/136347/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Allplex 2019-nCoV Assay - Seegene, Inc

URL: https://www.fda.gov/media/137177/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Allplex 2019-nCoV Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 21, 2020. The Allplex 2019-nCoV Assay is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: AvellinoCoV2 - Avellino Lab USA, Inc.

URL: https://www.fda.gov/media/136451/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the AvellinoCoV2, which received an Emergency Use Authorization from the Food and Drug Administration on March 25, 2020. The AvellinoCoV2 is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: BD SARS-CoV-2 Reagents for BD MAX System - BD

URL: https://www.fda.gov/media/136815/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BD SARS-CoV-2 Reagents for BD MAX System, which received an Emergency Use Authorization from the Food and Drug Administration on April 8, 2020. The BD SARS-CoV-2 Reagents for BD MAX System is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: BioFire® COVID-19 Test - BioFire Defense, LLC

URL: https://www.fda.gov/media/136357/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: BioGX SARS-CoV-2 Reagents for BD MAX System

URL: https://www.fda.gov/media/136652/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BioGX SARS-CoV-2 Reagents for BD MAX System, which received an Emergency Use Authorization from the Food and Drug Administration on April 2, 2020. The BioGX SARS-CoV-2 Reagents for BD MAX System is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: COV-19 IDx Assay- Ipsum Diagnostics, LLC

URL: https://www.fda.gov/media/136619/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COV-19 IDx assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 1, 2020. The COV-19 IDx assay is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: COVID-19 ELISA IgG Antibody Test - Mount Sinai

URL: https://www.fda.gov/media/137030/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COVID-19 ELISA IgG Antibody Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 15, 2020. The COVID-19 ELISA IgG Antibody Test is authorized for use on serum or plasma specimens from individuals suspected of prior infection with the virus that causes coronavirus disease 2019 (COVID-19) by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Curative-Korva SARS-Cov-2 Assay - KorvaLabs Inc.

URL: https://www.fda.gov/media/137087/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Curative-Korva SARS-Cov-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 16, 2020. The Curative-Korva SARS-Cov-2 Assay is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of Philips IntelliVue Patient Monitors MX750 and MX850, Philips IntelliVue 4-Slot Module Rack FMX-4, and Philips IntelliVue Active Displays AD75 and AD85 During the COVID-19 Pandemic

URL: https://www.fda.gov/media/137227/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Philips IntelliVue Patient Monitors MX750 and MX850; Philips IntelliVue 4-Slot Module Rack FMX-4; and Philips IntelliVue Active Displays AD75 and AD85, which received an Emergency Use Authorization from the Food and Drug Administration on April 22, 2020. These devices are authorized for emergency use by healthcare professionals in the hospital environment for the monitoring of patients having or suspected of having COVID-19, to reduce healthcare provider exposure to COVID-19.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of Seraph 100 Microbind Affinity Blood Filter for COVID-19

URL: https://www.fda.gov/media/137102/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Seraph 100 Microbind Affinity Blood Filter device for the reduction of pathogens and inflammatory mediators. The Seraph 100 Microbind Affinity Blood Filter device was authorized for emergency use by the Food and Drug Administration on April 17, 2020, to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge for COVID-19

URL: https://www.fda.gov/media/136836/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge for the reduction of pro-inflammatory cytokine levels, which received an Emergency Use Authorization from the Food and Drug Administration on April 9, 2020. The Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge is authorized for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of Ventilators During the COVID-19 Pandemic

URL: https://www.fda.gov/media/136424/download

Collection: Global Health Events web archive

Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories that are authorized for emergency use in healthcare settings for treatment of patients during the COVID-19 pandemic by their healthcare providers.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of the B. Braun Space and Outlook Pumps During the COVID-19 Pandemic

URL: https://www.fda.gov/media/136895/download

Collection: Global Health Events web archive

Description: The Food and Drug Administration issued an Emergency Use Authorization (EUA) for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (Braun Space and Outlook Pumps) for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of the CytoSorb Device for COVID-19

URL: https://www.fda.gov/media/136864/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the CytoSorb device for the reduction of pro-inflammatory cytokine levels, which received an Emergency Use Authorization from the Food and Drug Administration on April 10, 2020. The CytoSorb device is authorized for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of the TransAeris® Diaphragm Pacing System During the COVID-19 Pandemic

URL: https://www.fda.gov/media/136936/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the TransAeris® Diaphragm Pacing System during the COVID-19 pandemic, which received an Emergency Use Authorization from the Food and Drug Administration on April 13, 2020. The TransAeris® Diaphragm Pacing System is authorized for use in healthcare settings to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off ventilators, for no more than 30 days.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of the oXiris Set Device for COVID-19

URL: https://www.fda.gov/media/137265/download

Collection: Global Health Events web archive

Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the oXiris Set device for the reduction of pro-inflammatory mediators, which received an Emergency Use Authorization from the Food and Drug Administration on April 22, 2020. The oXiris Set device is authorized for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification, including use in continuous renal replacement therapy.

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Title: Fact Sheet for Healthcare Providers: Emergency Use of the of the Lungpacer Diaphragm Pacing Therapy System During the COVID-19 Pandemic

URL: https://www.fda.gov/media/136990/download

Collection: Global Health Events web archive

Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Lungpacer Diaphragm Pacing Therapy System during the COVID-19 pandemic, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. It is for use with patients with COVID-19 and other illnesses or conditions that require mechanical ventilation, who are not spontaneously breathing, and are expected to require prolonged ventilation.

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Title: Fact Sheet for Healthcare Providers: Fosun COVID-19 RT-PCR Detection Kit - Fosun Pharma USA Inc.

URL: https://www.fda.gov/media/137118/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Fosun COVID-19 RT-PCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 17, 2020. The Fosun COVID-19 RT-PCR Detection Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: GSTM COVID-19 RT-PCR KIT - GenoSensor LLC

URL: https://www.fda.gov/media/137091/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the GSTM COVID-19 RT-PCR KIT, which received an Emergency Use Authorization from the Food and Drug Administration on April 16, 2020. The GSTM COVID-19 RT-PCR KIT is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: GeneFinder COVID-19 Plus RealAmp Kit - OSANG Healthcare

URL: https://www.fda.gov/media/137114/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the GeneFinder COVID-19 Plus RealAmp Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 19, 2020. The GeneFinder COVID-19 Plus RealAmp Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Gnomegen COVID-19 RT-Digital PCR Detection Kit - Gnomegen LLC

URL: https://www.fda.gov/media/136736/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Gnomegen COVID-19 RT-Digital PCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 6, 2020. The Gnomegen COVID-19 RT-Digital PCR Detection Kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: ID NOW COVID-19 - Abbott Diagnostics Scarborough, Inc.

URL: https://www.fda.gov/media/136523/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ID NOW COVID-19, which received an Emergency Use Authorization from the Food and Drug Administration on March 27, 2020. The ID NOW COVID-19 is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Logix Smart COVID-19 Kit - Co-Diagnostics, Inc.

URL: https://www.fda.gov/media/136685/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Logix Smart Coronavirus Disease 2019 (COVID-19) kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The Logix Smart COVID-19 kit is authorized for use on using respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Lyra SARS-CoV-2 Assay; Quidel Corp.

URL: https://www.fda.gov/media/136226/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests

URL: https://www.fda.gov/media/136599/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Test (Molecular LDT COVID-19 Authorized Test) that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: NeuMoDx SARS-CoV-2 Assay - NeuMoDx Molecular, Inc.

URL: https://www.fda.gov/media/136564/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the NeuMoDx SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on March 30, 2020. The NeuMoDx SARS-CoV-2 Assay is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: NxTAG® CoV Extended Panel Assay - Luminex Corporation

URL: https://www.fda.gov/media/136498/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the NxTAG CoV Extended Panel Assay, which received an Emergency Use Authorization from the Food and Drug Administration on March 27, 2020. The NxTAG CoV Extended Panel Assay is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Panther Fusion® SARS-CoV-2 - Hologic, Inc.

URL: https://www.fda.gov/media/136154/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: PerkinElmer ® New Coronavirus Nucleic Acid Detection Kit - PerkinElmer Inc.

URL: https://www.fda.gov/media/136408/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on March 24, 2020. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: PhoenixDx® 2019-CoV - Trax Management Services Inc.

URL: https://www.fda.gov/media/137152/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the PhoenixDx® 2019-CoV, which received an Emergency Use Authorization from the Food and Drug Administration on April 20, 2020. The PhoenixDx® 2019-CoV is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: QIAstat-Dx Respiratory SARS-CoV-2 Panel - QIAGEN GmbH

URL: https://www.fda.gov/media/136568/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, which received an Emergency Use Authorization from the Food and Drug Administration on March 30, 2020. The QIAstat-Dx Respiratory SARS-CoV-2 Panel is authorized for use on respiratory specimens collected from patients suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: QuantiVirus SARS-CoV-2 Test Kit - DiaCarta, Inc.

URL: https://www.fda.gov/media/136807/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the QuantiVirus SARS-CoV-2 Test kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 8, 2020. The QuantiVirus SARS-CoV-2 Test kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: RealStar® SARS-CoV-2 RT-PCR Kit U.S. - altona Diagnostics GmbH

URL: https://www.fda.gov/media/137251/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the RealStar® SARS-CoV-2 RT-PCR Kit U.S., which received an Emergency Use Authorization from the Food and Drug Administration on April 22, 2020. The RealStar® SARS-CoV-2 RT-PCR Kit U.S. is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: SARS-CoV-2 Fluorescent PCR Kit - Maccura Biotechnology (USA) LLC

URL: https://www.fda.gov/media/137025/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the SARS-CoV-2 Fluorescent PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020. The SARS-CoV-2 Fluorescent PCR Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare providers.

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Title: Fact Sheet for Healthcare Providers: STANDARD M nCoV Real-Time Detection kit - SD BIOSENSOR, Inc.

URL: https://www.fda.gov/media/137301/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the STANDARD M nCoV Real-Time Detection kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 23, 2020. The STANDARD M nCoV Real-Time Detection kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit - ScienCell Research Laboratories

URL: https://www.fda.gov/media/136689/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Simplexa COVID-19 Direct Assay; DiaSorin Molecular LLC

URL: https://www.fda.gov/media/136285/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Smart Detect SARS-CoV-2 rRT-PCR Kit - InBios International, Inc.

URL: https://www.fda.gov/media/136785/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Smart Detect SARS-CoV-2 rRT-PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 7, 2020. The Smart Detect SARS-CoV-2 rRT-PCR Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: TaqPath COVID-19 Combo Kit

URL: https://www.fda.gov/media/136111/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: VITROS Immunodiagnostic Products Anti-SARS-CoV2 Total Reagent Pack Ortho-Clinical Diagnostics, Inc.

URL: https://www.fda.gov/media/136970/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test is authorized for use on serum and EDTA plasma specimens from individuals suspected of coronavirus disease 2019 (COVID-19) by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Xpert® Xpress SARS-CoV-2; Cepheid

URL: https://www.fda.gov/media/136313/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: cobas ® SARS-CoV-2

URL: https://www.fda.gov/media/136047/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: ePlex® SARS-CoV-2 Test; GenMark Diagnostics, Inc.

URL: https://www.fda.gov/media/136281/download

Collection: Global Health Events web archive

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