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Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Illinois. Department of Public Health
Language: English
Type: Fact sheet
Geographic Location: Illinois
Collector: National Library of Medicine (U.S.)
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: National Institutes of Health (U.S.), National Institute on Drug Abuse
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Vulnerable Populations, People with Substance Use Disorders
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: Drugs.com
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Biomedical Research
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: European Centre for Disease Prevention and Control
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Prevention and Control/Risk Management, Vaccines, Social Dimensions
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: Export-Import Bank of the United States
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Social Dimensions
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Vaccines, Patient Treatment and Experience, Prevention and Control/Risk Management
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Geographic Location: New York
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Basic Information
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Facilities, Patient Treatment and Experience
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Adapting Technology, Patient Treatment and Experience, Prevention and Control/Risk Management
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This Emergency Use Authorization was revoked on August 6, 2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Anti-SARS-CoV-2 Rapid Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 24, 2020. The Anti-SARS-CoV-2 Rapid Test 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
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 IgG assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 26, 2020. SARS-CoV-2 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the emergency use of the VitalPatch Biosensor when used in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care (not in the intensive care unit) patients who are 18 years of age or older and are undergoing treatment for COVID-19 drugs that can prolong QT intervals and may cause life threatening arrhythmias (e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin). Such remote monitoring may reduce healthcare provider exposure to SARS-CoV-2, the virus that causes COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 U-TOP COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 27, 2020. The U-TOP COVID-19 Detection 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 LabGun COVID-19 RT-PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 29, 2020. The LabGun COVID-19 RT-PCR 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Fresenius multiFiltrate PRO System and multiBic/multiPlus Solutions to provide continuous renal replacement therapy to treat patients in an acute care environment during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management
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 Bio-Rad SARS-CoV-2 ddPCR Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 1, 2020. The Bio-Rad SARS-CoV-2 ddPCR Testis authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 BioFire Respiratory Panel 2.1 (RP2.1), which received an Emergency Use Authorization from the Food and Drug Administration on May 1, 2020. The BioFire RP2.1 test is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 a protective barrier enclosure during the COVID-19 pandemic. The virus that causes COVID-19 is highly contagious, and the protective barrier enclosure provides an additional layer of protection when exposure to bodily fluids and airborne particles or droplets from COVID-19 patients are expected.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
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 VentFree Respiratory Muscle Stimulator, which received an Emergency Use Authorization from the Food and Drug Administration on May 1, 2020, in healthcare settings for treatment of mechanically ventilated adult patients during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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 FTD SARS-CoV-2 test, which received an Emergency Use Authorization from the Food and Drug Administration on May 5, 2020. The FTD SARS-CoV-2 test is authorized for use on respiratory specimens collected from individuals who are suspected of coronavirus disease 2019 (COVID-19) by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This four-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the PhysiolGuard ECG-QT Analysis System when used in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care (i.e., not in the intensive care unit) patients who are 18 years of age or older and are undergoing treatment for COVID-19 drugs that can prolong QT intervals and may cause life threatening arrhythmias (e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management
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 OPTI SARS-CoV-2 RT PCR Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 6, 2020. The OPTI SARS-CoV-2 RT PCR Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 R-GENE test, which received an Emergency Use Authorization from the Food and Drug Administration on May 6, 2020. The SARS-COV-2 R-GENE test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Sherlock CRISPR SARS-CoV-2 kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 6, 2020. The Sherlock CRISPR SARS-CoV-2 kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 7, 2020. The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay is authorized for use on respiratory specimens from individuals suspected of coronavirus disease 2019 (COVID-19) by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Quick SARS-CoV-2 rRT-PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 7, 2020. The Quick SARS-CoV-2 rRT-PCR Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Patient Isolation Transport Unit (PITU). The PITU is intended for use by healthcare providers (HCP) for temporary isolation and transport of patients with suspected or confirmed diagnosis of COVID-19 requiring airborne or droplet isolation precautions in healthcare settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment (PPE).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Facilities, Prevention and Control/Risk Management, Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheets informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Sofia 2 SARS Antigen FIA test, which received an Emergency Use Authorization from the Food and Drug Administration on May 8, 2020. The Sofia 2 SARS Antigen FIA test is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This nine-page details the Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL, to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit (ICU) setting during the 2019 coronavirus disease (COVID-19) pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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-qPCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 8, 2020. The Gnomegen COVID-19 RT-qPCR Detection Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Eko ECG Low Ejection Fraction Tool (ELEFT). This software device for diagnosing low Left Ventricular Ejection Fraction (LVEF) is for use by healthcare professionals (HCP) to provide an assessment of LVEF for use as a diagnostic aid to screen for potential cardiac complication associated with COVID-19 or underlying cardiac conditions that may affect clinical management of COVID-19, in adult patients having or suspected of having COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Patient Treatment and Experience, Vulnerable Populations, Pre-existing Medical Conditions
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 1copy COVID-19 qPCR Multi Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 11, 2020. The 1copy COVID-19 qPCR Multi Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Ascom teleCARE IP Nurse Call System. During the COVID-19 outbreak, the remote communication and monitoring capabilities of the teleCARE IP Nurse Call System may reduce the amount of contact by healthcare providers with patients who are in isolation rooms, thereby reducing healthcare provider risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Facilities, Patient Treatment and Experience, Health Workforce
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 Abbott Alinity m SARS-CoV-2 assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 11, 2020. The Abbott Alinity m 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Linea COVID-19 Assay Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 13, 2020. The Linea COVID-19 Assay 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 infusion pumps and infusion pump accessories. Certain infusion pumps and infusion pump accessories are authorized for emergency use by healthcare providers to treat conditions caused by the coronavirus disease 2019 (COVID-19) with the controlled infusion of medications, total parenteral nutrition (TPN), and/or other fluids.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Health Facilities
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 Aptima SARS-CoV-2 assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 14, 2020. The Aptima SARS-CoV-2 assay is authorized for use on respiratory specimens collected from individuals meeting COVID-19 clinical and/or epidemiological criteria.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 NeoPlex COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 14, 2020. The NeoPlex 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 G Medical VSMS ECG Patch. The VSMS Patch is authorized for emergency use in the hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) in general care (i.e., not in the intensive care unit) patients who are 18 years of age or older and are undergoing treatment for COVID-19 using drugs that can prolong the QT intervals and may cause life-threatening arrhythmias ( e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management, Health Workforce, Health Facilities
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 Fulgent COVID-19 by RT-PCR Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 15, 2020. The Fulgent COVID-19 by RT-PCR Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 infection by their healthcare provider or self-collected using a home collection kit specified in the test's instructions for use.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Assurance SARS-CoV-2 Panel, which received an Emergency Use Authorization from the Food and Drug Administration on May 15, 2020. The Assurance SARS-CoV-2 Panel is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 infection by their healthcare provider or self-collected using a home collection kit specified in the test's instructions for use.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Lyra Direct SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 18, 2020. The Lyra Direct 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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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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 Prismaflex ST Set to provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
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