Title: Coronavirus (COVID-19) frequently asked questions | CDC

URL: https://www.cdc.gov/coronavirus/2019-ncov/faq.html

Collection: Global Health Events web archive

Description: This web page provides answers to frequently asked questions about Coronavirus Disease 2019 Basics; How COVID-19 Spreads; How to Protect Yourself; COVID-19 and Children; School Dismissals and Children; Preparing Your Home and Family for COVID-19; In Case of an Outbreak in Your Community; Symptoms and Testing; Higher Risk; Healthcare Professionals and Health Departments; COVID-19 and Funerals; What CDC is Doing; and COVID-19 and Animals.

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Title: Personal Protective Equipment: Questions and Answers | CDC

URL: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html

Collection: Global Health Events web archive

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Title: The Public Health Approach to Violence Prevention

URL: https://www.cdc.gov/violenceprevention/pdf/PH_App_Violence-a.pdf

Collection: Violence as a Public Health Issue web archive

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Title: Monkeypox vs. COVID-19

URL: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Monkeypox-vs-COVID19.aspx

Collection: Global Health Events web archive

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Title: WHO’s Role During Health Emergencies

URL: https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200129-WHOsRole-factsheet.pdf

Collection: Global Health Events web archive

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Title: Financing for Epidemic Response Activities

URL: https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200129-finance-factsheet.pdf

Collection: Global Health Events web archive

Description: This two-page fact sheet, originally published on January 26, 2020, provides information about several major sources of money that could be used to support COVID-19 outbreak response activities, including the Pandemic Emergency Financing Facility, which could be used in a coronavirus pandemic; World Bank's International Development Association Crisis Response Window; International Monetary Fund; national governments; and private charity.

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Title: Diagnostic Testing for COVID-19

URL: https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200130-nCoV-diagnostics-factsheet.pdf

Collection: Global Health Events web archive

Description: Diagnostic testing for COVID-19 is undertaken using two approaches: whole genome sequencing, and real-time reverse transcriptase PCR (rRT-PCR). This two-page fact sheet, updated on April 17, 2020, details how sequencing was used primarily in the early days of the outbreak for initial identification of this novel virus and is largely a tool of viral discovery. Currently, almost all diagnostic testing for nCoV is done using rRT-PCR.

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Title: Blame and Discrimination Attached to 2019-nCoV - An FAQ for US Elected Leaders and Health Officials

URL: https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200205-nCoV-leadersAgainstStigma.pdf

Collection: Global Health Events web archive

Description: This two-page fact sheet answers frequently asked questions about blame and discrimination attached to 2019-nCoV (COVID-19), including what social stigma is in the context of a disease outbreak, and what political and health leaders can do to prevent stigmatization of people of Asian descent during the COVID-19 outbreak.

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Title: Ventilator Stockpiling and Availability in the United States

URL: https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200214-VentilatorAvailability-factsheet.pdf

Collection: Global Health Events web archive

Description: Because of the constraints of ventilator availability, public health planners may find the information in this two-page fact sheet useful when preparing hospitals for severe cases of COVID-19 that will require mechanical ventilation. To meet a potential surge in demand, the Centers for Disease Control and Prevention Strategic National Stockpile (SNS) stores and maintains mechanical ventilators that can be deployed on request through appropriate channels.

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Title: Serology Testing for COVID-19

URL: https://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200228-Serology-testing-COVID.pdf

Collection: Global Health Events web archive

Description: This document provides information about serology testing, and why this method for COVID-19 (coronavirus disease) is attractive because of the relatively short time to diagnosis and the ability to test for an active immune response against the virus. The fact sheet discusses past coronavirus outbreaks and serology, and next steps in serology testing.

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Title: Kids’ COVID Vaccine: Myths vs. Facts - Children's Health Fund: Access to Healthcare for Children Living in Underserved Communities

URL: https://www.childrenshealthfund.org/kids-covid-vaccine-myths-vs-facts/

Collection: Global Health Events web archive

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Title: COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing

URL: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

Collection: Global Health Events web archive

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Title: Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions (FAQs) for Non LongTerm Care Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IIDs)

URL: https://www.cms.gov/files/document/covid-faqs-non-long-term-care-facilities-and-intermediate-care-facilities-individuals-intellectual.pdf

Collection: Global Health Events web archive

Description: The purpose of this 18-page FAQs document is to clarify existing COVID-19 guidance and flexibilities, and provide stakeholders with additional information based on questions received regarding the following entities: Ambulatory Surgical Centers (ASCs); Hospitals and Critical Access Hospitals (CAHs); Hospice; Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID); and Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs).

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Title: Frequently Asked Questions: COVID-19 Testing at Skilled Nursing Facilities/ Nursing Homes

URL: https://www.cms.gov/files/document/covid-faqs-snf-testing.pdf

Collection: Global Health Events web archive

Description: This eight-page document provides answers to 27 frequently asked questions about COVID-19 testing at skilled nursing facilities and nursing homes.

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Title: Nursing Home Reopening Recommendations Frequently Asked Questions

URL: https://www.cms.gov/files/document/covid-nursing-home-reopening-recommendation-faqs.pdf

Collection: Global Health Events web archive

Description: This five-page fact sheet answers a range of questions for nursing homes on the topics of reopening, visitation, and testing requirements during the COVID-19 pandemic.

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Title: Medicare Telehealth Frequently Asked Questions (FAQs)

URL: https://www.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf

Collection: Global Health Events web archive

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Title: Medicare Telemedicine Health Care Provider Fact Sheet | CMS

URL: https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet

Collection: Global Health Events web archive

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Title: Caring for Patients' Mental Well-Being During Coronavirus and Other Emerging Infectious Diseases

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Caring_for_Patients_Mental_WellBeing_during_Coronavirus.pdf

Collection: Global Health Events web archive

Description: This two-page fact sheet discusses how the early stages of an emerging infectious disease outbreak such as the novel coronavirus may lead to significant and understandable emotional distress, even among those who have not been, and don't know if they will be, directly exposed to the disease. It provides recommendations for promoting patients' mental well-being during emerging infectious disease outbreaks. It is one of a series of educational fact sheets that provide information and recommendations for healthcare personnel, families, businesses, and communities during this emerging infectious disease outbreak.

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Title: Leaders' Guide to Risk Communication in the Face of Coronavirus and Other Emerging Public Health Threats

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Coronavirus_Leaders_Guide_to_Risk_Communication_in_the%20Face_of_Emerging_Threats_Outbreaks.pdf

Collection: Global Health Events web archive

Description: This one-page fact sheet discusses the need for community members to be prepared for emerging public health threats, such as the novel coronavirus or other infectious disease outbreaks, through timely, accurate, and updated public health education information, which is best delivered using effective, ongoing risk communication. It details how leaders can enhance the ability of community members to manage the unique psychological stressors of emerging public health threats. It is one of a series of educational fact sheets that provide information and recommendations for healthcare personnel, families, businesses, and communities during this emerging infectious disease outbreak.

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Title: Coronavirus Preparedness and Response: Critical Elements for Business Planning

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Coronavirus_Preparedness_and_Response_Critical_Elements_for_Business_Planning.pdf

Collection: Global Health Events web archive

Description: This one-page fact sheet describes how preparing for and responding to infectious outbreaks, such as the novel coronavirus (nCoV), is a shared responsibility involving government (local, state and federal) and the private sector, and provides points to be incorporated into workplace and business pandemic planning to sustain employee health, mental health, and productivity. It is one of a series of educational fact sheets that provide information and recommendations for healthcare personnel, families, businesses, and communities during this emerging infectious disease outbreak.

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Title: Discussing Coronavirus with Your Children

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Discussing_Coronavirus_w_Your_Children.pdf

Collection: Global Health Events web archive

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Title: Coronavirus and Emerging Infectious Disease Outbreaks: How Healthcare Personnel Can Support Military Families and Their Health

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Emerging_Infectious_Outbreaks_How_Healthcare_Personnel_Can_Support_Military_Families.pdf

Collection: Global Health Events web archive

Description: This two-page fact sheet discusses how public health emergencies, such as the novel coronavirus (nCoV) and others involving a global pandemic, create numerous opportunities and challenges around public health communication, preparedness, and response, including for military personnel. It details the unique characteristics of military family life that may increase exposure to disease, and how to support the psychological well-being of patients. It is one of a series of educational fact sheets that provide information and recommendations for healthcare personnel, families, businesses, and communities during this emerging infectious disease outbreak.

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Title: Finding the Right Words to Talk with Children and Teens about Coronavirus

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Finding_Right_Words_Talk_Children_Teens_Coronavirus.pdf

Collection: Global Health Events web archive

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Title: Grief Leadership During COVID-19

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Grief_Leadership_During_COVID19.pdf

Collection: Global Health Events web archive

Description: This two-page fact sheet discusses how the COVID-19 pandemic has put in perspective the need for leaders to prepare for disruption of work routines, anxiety within their communities and organizations, and even death of community members, friends, and team members. Understanding people's reactions to the losses associated with tragic events informs the roles that leaders can play in support of recovery.

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Title: Mental Health and Behavioral Guidelines for Preparedness and Response to Coronavirus and Other Emerging Infectious Outbreaks

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Mental_Health_Behavioral_Guidelines_Response_to_Coronavirus_Outbreak.pdf

Collection: Global Health Events web archive

Description: The first step in preventing undesirable psychological, emotional, and behavioral response to an emerging infectious disease outbreak such as the novel coronavirus is an effective public health program of risk assessment and communication, public health prevention, and consequence management. This three-page fact sheet details recommended steps in response to a pandemic flu outbreak in four phases: preparedness, early outbreak response, later response and recovery, and mental health intervention planning. It is one of a series of educational fact sheets that provide information and recommendations for healthcare personnel, families, businesses, and communities during this emerging infectious disease outbreak.

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Title: Taking Care of Patients During the Coronavirus Outbreak: A Guide for Psychiatrists

URL: https://www.cstsonline.org/assets/media/documents/CSTS_FS_Taking_Care_of_Patients_During_Coronavirus_Outbreak_A_Guide_for_Psychiatrists_03_03_2020.pdf

Collection: Global Health Events web archive

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Title: Fentanyl (Trade Names: Actiq®, FentoraTM, Duragesic®)

URL: https://www.deadiversion.usdoj.gov/drug_chem_info/fentanyl.pdf

Collection: Opioid Epidemic web archive

Description: Fact sheet published by the Drug Enforcement Administration (DEA) on December 2016 on the synthetic opioid Fentanyl, including its illicit and licit uses, effects, clandestine manufacture, and control status.

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Title: Fact Sheet: DHS Measures on the Border to Limit the Further Spread of Coronavirus | Homeland Security

URL: https://www.dhs.gov/news/2020/06/16/fact-sheet-dhs-measures-border-limit-further-spread-coronavirus

Collection: Global Health Events web archive

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Title: Fact Sheet: DHS Measures on the Border to Limit the Further Spread of Coronavirus | Homeland Security

URL: https://www.dhs.gov/news/2020/10/19/fact-sheet-dhs-measures-border-limit-further-spread-coronavirus/

Collection: Global Health Events web archive

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Title: Fact Sheet: Guidance for Travelers to Enter the U.S. at Land Ports of Entry and Ferry Terminals | Homeland Security

URL: https://www.dhs.gov/news/2021/10/29/fact-sheet-guidance-travelers-enter-us-land-ports-entry-and-ferry-terminals

Collection: Global Health Events web archive

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Title: Master Question List | Homeland Security

URL: https://www.dhs.gov/publication/st-master-question-list-covid-19

Collection: Global Health Events web archive

Description: This Master Question List (MQL), updated on August 18, 2020, is intended to quickly present the current state of available information to government decision-makers in the operational response to COVID-19, and allow structured and scientifically guided discussions across the federal government without burdening them with the need to review scientific reports, and to prevent duplication of efforts by highlighting and coordinating research. This document is a "living document" that will be updated as needed when new information becomes available.

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Title: Frequently Asked Questions: COVID-19 and Diabetes | ADA

URL: https://www.diabetes.org/coronavirus-covid-19/how-coronavirus-impacts-people-with-diabetes

Collection: Global Health Events web archive

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Title: COVID-19 Vaccine | IDPH

URL: https://www.dph.illinois.gov/covid19/vaccine-faq

Collection: Global Health Events web archive

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Title: FAQs on COVID-19 and Addiction/Substance Use Disorder

URL: https://www.drugabuse.gov/sites/default/files/final_faqs_for_covid19page_051820_optimized.pdf

Collection: Global Health Events web archive

Description: This five-page fact sheet provides answers to questions about what people with an addiction or a substance use disorder should know about COVID-19, and a list of additional resources.

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Title: Can Ivermectin be used to treat COVID-19?

URL: https://www.drugs.com/medical-answers/ivermectin-treat-covid-19-coronavirus-3535912/

Collection: Global Health Events web archive

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Title: Questions and answers on COVID-19

URL: https://www.ecdc.europa.eu/en/covid-19/questions-answers

Collection: Global Health Events web archive

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Title: Flint Residents: You and Your Family Need Water Here’s a Quick Reference Guide to Making it Safe

URL: https://www.epa.gov/sites/production/files/2016-03/documents/flint_oh_fsv4.pdf

Collection: Environmental Health web archive

Description: Fact sheet titled, "Flint Residents: You and Your Family Need Water. Here's a Quick Reference Guide to Making it Safe," published by the Enivronmental Protection Agency (EPA). The sheet features illustrated instructions for safe water use in Flint, Michigan in the wake of the water contamination crisis.

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Subject:   Lead in Flint, Michigan Water System

Title: Getting Clean Water to Flint

URL: https://www.epa.gov/sites/production/files/2016-03/documents/flint_oh_sampl_final_eng2_0.pdf

Collection: Environmental Health web archive

Description: Fact sheet titled, "Getting Clean Water to Flint," published by the Environmental Protection Agency (EPA). The sheet illustrates how lead got into the drinking water in Flint, Michigan, how the bottled water Flint residents are using to replace their water is sourced, and what the state needs to do to improve the city's water supply system.

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Subject:   Lead in Flint, Michigan Water System

Title: Fact Sheet | EXIM.gov

URL: https://www.exim.gov/fact-sheet-exim-covid-19-assistance/

Collection: Global Health Events web archive

Description: Fact sheet providing information on relief measures offered by EXIM in support of America's exporters during the coronavirus pandemic.

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Title: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions | FDA

URL: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions

Collection: Global Health Events web archive

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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: New York SARS-CoV-2 Real-time RT-PCR Diagnostic Panel

URL: https://www.fda.gov/media/135662/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: 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 Laboratory Corporation of America (“Labcorp”) COVID-19 RT-PCR Test

URL: https://www.fda.gov/media/136149/download

Collection: Global Health Events web archive

Description: This three-page fact sheet, updated on July 24, 2020, informs healthcare providers of the significant known and potential risks and benefits of the emergency use of LabCorp's COVID-19 RT-PCR test. The Food and Drug Administration reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing.

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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: 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 Quest Diagnostics Quest SARS-CoV-2 rRT-PCR

URL: https://www.fda.gov/media/136229/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 Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR (Quest SARS-CoV-2 rRT-PCR) test, which received an Emergency Use Authorization from the Food and Drug Administration on March 17, 2020. The Quest SARS-CoV-2 rRT-PCR test is authorized for use on respiratory specimens from individuals suspected of COVID-19 (coronavirus) by their healthcare provider. The U.S. Food and Drug Administration reissued an emergency use authorization (EUA) on July 18, 2020, to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation.

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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: 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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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: 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: 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: 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: 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: 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: 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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URL: https://www.fda.gov/media/136471/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 Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV, which received an Emergency Use Authorization from the Food and Drug Administration on March 26, 2020. The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV 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: 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: 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 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 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: 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: 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: 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: qSARS-CoV-2 lgG/lgM Rapid Test-Cellex Inc.

URL: https://www.fda.gov/media/136623/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 qSARS-CoV-2 lgG/lgM Rapid Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 1, 2020. The qSARS-CoV-2 lgG/lgM Rapid Test is authorized for use on serum, plasma, or venipuncture whole blood specimens from people suspected of Coronavirus Disease 2019 (COVID-19) by their healthcare provider.

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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: 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: 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: 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: 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: 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: 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: 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: 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 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 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: iAMP COVID-19 Detection Kit - Atila BioSystems, Inc.

URL: https://www.fda.gov/media/136869/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 iAMP COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 10, 2020. The iAMP COVID-19 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 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 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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 Hemolung RAS

URL: https://www.fda.gov/media/137279/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the potential benefits and risks associated with use of a critical care lung support device called the Hemolung Respiratory Assist System (RAS). Hemolung therapy is referred to as extracorporeal carbon dioxide removal (ECCO2R), or respiratory dialysis. The FDA has made Hemolung RAS available under an Emergency Use Authorization (EUA) for treatment of lung failure in COVID-19 patients when used as an adjunct to noninvasive or invasive mechanical ventilation to reduce hypercapnia and hypercapnic acidosis, and/or to maintain normalized levels of partial pressure of carbon dioxide (PCO2) and pH, in patients suffering from acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.

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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 DiaSorin, Inc. LIAISON SARS-CoV-2 S1/S2 IgG assay

URL: https://www.fda.gov/media/137357/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 LIAISON SARS-CoVs S1/S2 IgG assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 24, 2020. The LIAISON SARS-CoVs S1/S2 IgG assay can be ordered by a healthcare provider to detect if there has been an adaptive immune response to COVID-19, indicating a recent or prior infection.

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Title: FACT SHEET FOR HEALTHCARE PROVIDERS Ortho-Clinical Diagnostics, Inc. Updated: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack

URL: https://www.fda.gov/media/137361/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 IgG Reagent Pack assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 24, 2020. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack assay can be ordered by a healthcare provider to detect if there has been an adaptive immune response to COVID-19, indicating a recent or prior infection.

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