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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
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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
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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 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 provides answers to frequently asked questions about the revocation of the Emergency Use Authorization for hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19. The Food and Drug Administration has determined that these drugs are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.
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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
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.)
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.)
Collection: Global Health Events web archive
Description: This web page provides answers to frequently asked questions for entities who use 3D printing of devices, accessories, components, and/or parts during the COVID-19 emergency. The Food and Drug Administration recognizes that the public may seek to use 3D printing to assist in meeting demand for certain products during the COVID-19 pandemic.
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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, Prevention and Control/Risk Management
Collection: Global Health Events web archive
Description: This web page answers questions about adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of COVID-19-related guidance documents, and points out a number of adverse event reporting-related resources.
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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
Collection: Global Health Events web archive
Description: This web page, updated regularly, provides answers to frequently asked questions relating to the development and performance of tests for SARS-CoV-2.
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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
Collection: Global Health Events web archive
Description: This web page is intended to address questions related to the design, evaluation, labeling, and marketing of hospital beds, stretchers, and mattresses during the COVID-19 public health emergency.
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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
Collection: Global Health Events web archive
Description: This web page provides answers to frequently asked questions about Emergency Use Authorizations (EUAs) and medical devices during the COVID-19 pandemic.
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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
Collection: Global Health Events web archive
Description: This resource provides information about the Food and Drug Administration (FDA)'s issuance of an Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Novel Coronavirus 2012 Real-time RT-PCR Assay to test for the presumptive presence of Middle East respiratory syndrome coronavirus (MERS-CoV) in the following clinical specimens: upper respiratory specimens, such as nasopharyngeal swabs and oropharyngeal swabs; lower respiratory specimens, such as bronchoalveolar lavage, bronchial wash, tracheal aspirate, and sputum; serum; and stool.
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Group: Middle East respiratory syndrome coronavirus (MERS-CoV)
Creator: United States. Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Prevention and Control/Risk Management
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