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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 one-page letter authorizes the emergency use of the Warrior Diagnostics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Doss, Megan, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
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 AQ-TOP COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 21, 2020. The AQ-TOP COVID-19 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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Access IL-6. The Access IL-6 is authorized for use in human serum and plasma specimens collected from patients with confirmed coronavirus disease-2019 (COVID-19) to assist in identifying severe inflammatory response to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory 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: Patient Treatment and Experience, Health Facilities
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the MassARRAY SARS-CoV-2 Panel. The MassARRAY SARS-CoV-2 Panel is authorized for use with 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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Alimetrix SARS-CoV-2 RT-PCR Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain 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 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: The purpose of this 15-page review is for the Division of Pharmacovigilance II to provide the Division of Antiviral Drug Products a high-level overview of the postmarketing safety data related to the use of hydroxychloroquine and chloroquine in the setting of coronavirus disease 2019 (COVID-19). It identifies two emerging safety signals.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States. Department of Health and Human Services, Public Health Service, United States Food and Drug Administration , 80126147, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology
Language: English
Type: Report
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
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 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: The FDA is issuing this 14-page guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Vulnerable Populations, Children
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 one-page letter authorizes the emergency use of the Avera Institute for Human Genetics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Ehli, Erik, Scherf, Uwe
Language: English
Type: Letter
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 Veritorâ„¢ System for Rapid Detection of SARS-CoV-2. The BD Veritorâ„¢ System for Rapid Detection of SARS-CoV-2 is authorized for use using nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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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 BinaxNOW™ COVID-19 Ag Card. The BinaxNOW™ COVID-19 Ag Card is authorized for use using nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.
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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 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 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 BioCore 2019-nCoV Real Time PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 21, 2020. The BioCore 2019-nCoV Real Time PCR Kit is authorized for use with upper and lower 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 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-EZ (RP2.1-EZ). The BioFire RP2.1-EZ is authorized for use with nasopharyngeal swab 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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the CentoSure SARS-CoV-2 RT-PCR Assay. The CentoSure SARS-CoV-2 RT-PCR Assay is authorized for use with dry oropharyngeal swab specimens from individuals without symptoms or other reasons to suspect 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 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), which received an Emergency Use Authorization from the Food and Drug Administration on May 29, 2020. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is authorized for the detection of IgG and IgM antibodies against SARS-CoV-2 in human serum, plasma (EDTA, lithium heparin, and sodium citrate), or venous whole blood.
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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 one-page letter authorizes the emergency use of the COVID-19 Key Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Sanford, Nicholas, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This project aims to harmonize a list of COVID-19 data elements with several Common Data Models (CDMs) and open standards. This web page provides information about the project and a mapping table, which is a continuously evolving document intended to serve as a resource.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the CareStart™ COVID-19 Antigen test. The CareStart™ COVID-19 Antigen test is authorized for use using nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Sampinute™ COVID-19 Antigen Magnetic Immunoassay (MIA). The Sampinute™ COVID-19 Antigen MIA is authorized for use using nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Xpert Xpress SARS-CoV-2/Flu/RSV test. The Xpert Xpress SARS-CoV-2/Flu/RSV test is authorized for use with certain respiratory specimens collected from individuals suspected of respiratory viral infection consistent with 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: Website from Food and Drug Administriation regarding certain COVID-19 tests that shouldn't be used.
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Creator: United States Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Color SARS-CoV-2 LAMP Diagnostic Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Zhou, Alicia Y., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: Website from Food and Drug Administration regarding respirators for health care facilities, links include how to identify what is needed, and other
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Health Facilities
Collection: Global Health Events web archive
Description: This 38-page document is a briefing paper for a meeting to be held on October 22, 2020, to discuss studies that should be conducted, pre- and/or post-licensure, to evaluate the safety and efficacy of COVID-19 vaccine candidates, including in special populations (e.g., pediatric populations and pregnant women), and to further evaluate the immunogenicity and duration of effectiveness of these vaccines. The committee will also be asked to discuss the need for post-marketing safety studies following approval of a Biologics License Application (BLA) for a COVID-19 vaccine.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Report
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Basic Information
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the DSL COVID-19 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swabs) and bronchioalveolarlavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hoffman, Tony, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This 24-page guidance was issued to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19, and describes the FDA's current recommendations regarding the data needed to facilitate clinical development and licensure of vaccines to prevent COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines
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 DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 21, 2020. The DiaPlexQ 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 five-page fact sheet provides information for healthcare providers about the Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product COVID-19 convalescent plasma to treat hospitalized patients with 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: Health Workforce
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) updated this Emergency Use Authorization (EUA) on October 1, 2020, to permit the emergency use of the unapproved product remdesivir for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and children hospitalized with severe disease. The FDA approved remdesivir for the treatment of COVID-19 requiring hospitalization on October 22, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Low, Madelyn, O'Shaughnessy, Jacqueline A.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Biomedical Research
Collection: Global Health Events web archive
Description: Website from the U.S. Food and Drug Administration providing background and research information on serology testing with relation to COVID-19. Serology tests detect antibodies in the blood which result from the body's response to an infection.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Biomedical Research
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 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 one-page letter authorizes the emergency use of the Corneum SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Vigerust, David, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
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 Elecsys IL-6. The Elecsys IL-6 is authorized for use in human serum and plasma specimens collected from patients with confirmed COVID-19 to identify severe inflammatory response by their healthcare provider to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory 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: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) has issued this 18-page guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Biologics Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Vaccines, Basic Information
Collection: Global Health Events web archive
Description: Website from the Food and Drug Administration with information rearding emergency use authorizations for medical devices; links to information about COVID-19, Monkeypox, Zika, Ebola and more
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Website
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
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 Impella RP System. The Impella RP is authorized for emergency use in the hospital setting to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation due to COVID-19 related complications, including pulmonary embolism (PE).
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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 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 CLEWICU System for use by healthcare providers in the Intensive Care Unit (ICU) in patients who are 18 years of age or older for the computation of proprietary patient status indices referred to as CLEWRF and CLEWHI as an adjunct to patient monitoring during the coronavirus disease 2019 (COVID-19) outbreak. These indices provide predictive screening information to assist with the early identification of patients who are likely to be diagnosed with respiratory failure or hemodynamic instability.
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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, Vulnerable Populations, Pre-existing Medical Conditions
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COViage System (or "COViage") for use by healthcare providers in the hospital setting for adult patients (18 years of age or older who are admitted to the hospital) with confirmed COVID-19 (based on a positive PCR test result) for the computation of proprietary patient status indices referred to as Respiratory Decompensation Status and Hemodynamic Instability Status as an adjunct to patient monitoring during the COVID-19 outbreak.
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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, Patient Treatment and Experience, Health Facilities
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of COVIAGE. This device is authorized for use by healthcare personnel (HCP) as an extra layer of protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, when performing airway-related medical procedures, or during certain transport of such 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: Health Workforce, Prevention and Control/Risk Management, 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 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 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
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 letter authorizes the emergency use of the EmpowerDX At-Home COVID-19 PCR Test Kit for use by individuals to self-collect nasal swabs at home, when determined by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-CoV-2 RNA that are indicated for use with the EmpowerDX At-Home COVID-19 PCR Test Kit.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Lunn, Randee K., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This 14-page guidance provides a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare professionals during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , National Center for Devices and Radiological Health (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Workforce
Collection: Global Health Events web archive
Description: This nine-page guidance was issued to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza (flu) viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses (RSV), during the influenza season and for the duration of the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Devices and Radiological Health (U.S.), Office of Product Evaluation and Quality
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Biomedical Research, Basic Information
Collection: Global Health Events web archive
Description: The FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of 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: Government directive
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Patient Treatment and Experience
Collection: Global Health Events web archive
Description: The FDA is issuing this 12-page guidance to help facilitate the availability of devices for use in transporting certain clinical specimens, including transport media that can be used to transport certain clinical specimens for use with molecular Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) assays or antigen-detection diagnostic SARS-CoV-2 assays for the duration of the COVID-19 public health emergency.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , National Center for Devices and Radiological Health (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization for the Everlywell COVID-19 Test Home Collection Kit, which is intended to facilitate self-collection of nasal swab specimens at home by individuals when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Kwo, Liz, Shuren, Jeffery E.
Language: English
Type: Letter
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 personnel of the significant known and potential risks and benefits of the emergency use of authorized disposable, single-use surgical masks during the COVID-19 pandemic. It is specific to surgical masks that were authorized by the Food and Drug Administration (FDA) under an emergency use authorization (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: 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 Vibrant COVID-19 Ab Assay. The Vibrant COVID-19 Ab Assay is authorized for the detection of IgM and IgG antibodies to SARS-CoV-2 in dried blood spots (DBS) and human serum.
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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 TRUPCR SARS-CoV-2 Kit. The TRUPCR SARS-CoV-2 Kit is authorized for use with 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: 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 a Molecular LDT COVID-19 Authorized Test called the OraRisk COVID-19 RT-PCR 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 certain 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: 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 BioCode SARS-CoV-2 Assay. The BioCode SARS-CoV-2 Assay is authorized for use with 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: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet, updated on September 23, 2020, informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Assure COVID-19 IgG/IgM Rapid Test Device. The Assure COVID-19 IgG/IgM Rapid Test Device is authorized for the detection of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA).
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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 Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test. The Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test is authorized for the detection of antibodies to SARS-CoV-2 in human serum, plasma (Lithium-Heparin, Sodium-Citrate and Acid Citrate Dextrose (ACD)) and venous whole blood (Lithium-Heparin, Sodium-Citrate and Dipotassium EDTA).
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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 BayCare SARS-CoV-2 RT PCR Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The BayCare SARS-CoV-2 RT PCR Assay is authorized for use on nasopharyngeal swab 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: 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 Wantai SARS-CoV-2 RT-PCR Kit. The Wantai SARS-CoV-2 RT-PCR Kit is authorized for use with oropharyngeal swab 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: 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 qSanger-COVID-19 Assay. The qSanger-COVID-19 Assay is authorized for use with upper 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: 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 Bio-Speedy Direct RT-qPCR SARS-CoV-2. The Bio-Speedy Direct RT-qPCR SARS-CoV-2 is authorized for use with 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: 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 Biomeme SARS-CoV-2 Real-Time RT-PCR Test. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is authorized for use with 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: 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 COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit. The COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit is authorized for use with 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: 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 CareStart COVID-19 MDx RT-PCR test. The CareStart COVID-19 MDx RT-PCR test is authorized for use with upper 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: Health Workforce
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 Centers for Disease Control and Prevention (CDC)'s Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. Testing is to be conducted on specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
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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 CentoFast-SARS-CoV-2 RT-PCR Assay. The CentoFast-SARS-CoV-2 RT-PCR Assay is authorized for use with dry oropharyngeal swab 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: 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 HDPCR SARS-CoV-2 Assay. The HDPCR SARS-CoV-2 Assay is authorized for use with 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: 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 Clear Dx SARS-CoV-2 Test. The Clear Dx SARS-CoV-2 Test is authorized for use with 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: 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 a Molecular LDT COVID-19 Authorized Test called the Cleveland Clinic SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain 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: 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 CRL Rapid Response test, which includes the DNA Genotek OMNIgene ORAL OM-505 collection device, that has been authorized for emergency use with saliva 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: 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 a Molecular LDT COVID-19 Authorized Test called the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain 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: 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 Compass Laboratory Services SARS-CoV2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Compass Laboratory Services SARS-CoV2 Assay is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider or self-collected using a home collection kit specified in the test's labeling.
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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 Cue COVID-19 Test. The Cue COVID-19 Test is authorized for use with direct nasal swab 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: 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 DIAGNOVITAL SARS-CoV-2 Real-Time PCR Kit. The DIAGNOVITAL SARS-CoV-2 Real-Time 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: 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 DTPM COVID-19 RT-PCR Test. The DTPM COVID-19 RT-PCR Test is authorized for use with nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swab 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: 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 QuantiVirus SARS-CoV-2 Multiplex Test Kit. The QuantiVirus SARS-CoV-2 Multiplex Test Kit is authorized for use with upper respiratory specimens and sputum 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: 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 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 DxTerity SARS-CoV-2 RT-PCR Test. he DxTerity SARS-CoV-2 RT-PCR Test is authorized for use with saliva 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: 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 EURORealTime SARS-CoV-2. The EURORealTime SARS-CoV-2 is authorized for use with 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: 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 Impella Left Ventricular (LV) Support Systems. The Impella LV Support Systems are authorized for emergency use by healthcare providers (HCP) in the hospital setting for providing temporary LV unloading and support to treat critical care patients with confirmed COVID-19 infection who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and who develop pulmonary edema while on veno-arterial (V-A) ECMO support or late cardiac decompensation from myocarditis while on veno-venous (V-V) ECMO support.
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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 four-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the gammaCore Sapphire CV during the coronavirus disease 2019 (COVID-19) pandemic. The gammaCore Sapphire CV is intended for acute use at home or in healthcare settings to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using non-invasive vagus nerve stimulation (VNS) on either side of the patient's neck 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 Workforce
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 Airway Dome. This device is authorized for use by healthcare providers (HCP) as an extra layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, or when performing airway-related medical procedures, or during certain transport of such 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: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers (HCP) of the significant known and potential risks and benefits of the emergency use of the Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100). This device is authorized for use by HCP as an extra layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, when performing medical procedures, or during transport of such 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: Health Workforce
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 Prismaflex HF20 Set to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume 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: 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 AMPIPROBE SARS-CoV-2 Test System. The AMPIPROBE SARS-CoV-2 Test System is authorized for use with upper 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: 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 Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay is authorized for use on certain 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: 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 Fastplex Triplex SARS-CoV-2 Detection Kit (RT-digital PCR). The Fastplex Triplex SARS-CoV-2 Detection Kit (RT-digtial PCR) is authorized for use with oropharyngeal swab 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: 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 GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT. The GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT is authorized for use with upper 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: 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 GenePro SARS-CoV-2 Test. The GenePro SARS-CoV-2 Test is authorized for use with 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: 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 Genetron Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing), also known as the Genetron SARS-CoV-2 RNA Test. The Genetron SARS-CoV-2 RNA Test is authorized for use with 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: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the emergency use of a Molecular LDT COVID-19 Authorized Test called the GWU COVID-19 RT-PCR 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 certain 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: 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 RightSign COVID-19 IgG/IgM Rapid Test Cassette. RightSign COVID-19 IgG/IgM Rapid Test Cassette is authorized for the detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, or venous whole blood (sodium heparin, potassium EDTA, and sodium citrate).
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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
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