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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 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: Website from Food and Drug Administration regarding 'information for Health Care Facilities and providers "in-use time" ' about COVID-19
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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: Website portal for US FDA monkeypox response including fast facts, vaccines, and fraud and misinformation resources
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Group: Mpox (monkeypox) outbreak 2022
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, updated on July 24, 2020, informs healthcare providers of the significant known and potential risks and benefits of the emergency use of LabCorp's COVID-19 RT-PCR test. The Food and Drug Administration reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR (Quest SARS-CoV-2 rRT-PCR) test, which received an Emergency Use Authorization from the Food and Drug Administration on March 17, 2020. The Quest SARS-CoV-2 rRT-PCR test is authorized for use on respiratory specimens from individuals suspected of COVID-19 (coronavirus) by their healthcare provider. The U.S. Food and Drug Administration reissued an emergency use authorization (EUA) on July 18, 2020, to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
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: This 10-page Letter of Authorization was updated on June 6, 2020, with five revisions regarding the emergency use of the authorized respirators, as described in the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) of this letter for use in healthcare settings by healthcare providers when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during filtering facepiece respirator shortages resulting from the COVID-19 outbreak.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , 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 nine-page letter, revised on June 6, 2020, updates the April 3, 2020, Emergency Use Authorization for certain product classifications for imported disposable filtering facepiece respirators that are manufactured in China and not approved by the Centers for Disease Control and Prevention's National Institute of Occupational Safety and Health (NIOSH). The Scope of Authorization was revised such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , 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 one-page document authorizes the emergency use of the Stanford SARS-CoV-2 PCR 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 , Kong, Christina S., 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 seven-page document, updated on April 24, 2020, details how the emergency use of face masks by the general public and healthcare workers, in accordance with Centers for Disease Control and Prevention recommendations, as personal protective equipment to help prevent spread of the virus during the COVID-19 pandemic meets the criteria for issuance of an Emergency Use Authorization.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , 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 three-page fact sheet informs healthcare providers of the potential benefits and risks associated with use of a critical care lung support device called the Hemolung Respiratory Assist System (RAS). Hemolung therapy is referred to as extracorporeal carbon dioxide removal (ECCO2R), or respiratory dialysis. The FDA has made Hemolung RAS available under an Emergency Use Authorization (EUA) for treatment of lung failure in COVID-19 patients when used as an adjunct to noninvasive or invasive mechanical ventilation to reduce hypercapnia and hypercapnic acidosis, and/or to maintain normalized levels of partial pressure of carbon dioxide (PCO2) and pH, in patients suffering from acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LIAISON SARS-CoVs S1/S2 IgG assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 24, 2020. The LIAISON SARS-CoVs S1/S2 IgG assay can be ordered by a healthcare provider to detect if there has been an adaptive immune response to COVID-19, indicating a recent or prior infection.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 24, 2020. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack assay can be ordered by a healthcare provider to detect if there has been an adaptive immune response to COVID-19, indicating a recent or prior infection.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This Emergency Use Authorization was revoked on August 6, 2020. This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Anti-SARS-CoV-2 Rapid Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 24, 2020. The Anti-SARS-CoV-2 Rapid Test can be ordered by a healthcare provider to detect if there has been an adaptive immune response to COVID-19, indicating a recent or prior infection.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This 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 one-page letter authorizes the emergency use of the UDX SARS-CoV-2 Molecular 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 , Tab, Sean, 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 one-page letter authorizes the emergency use of the AIT Laboratories 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 , Grnager, John K., 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 SARS-CoV-2 IgG assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 26, 2020. SARS-CoV-2 IgG assay can be ordered by a healthcare provider to detect if there has been an adaptive immune response to COVID-19, indicating a recent or prior infection.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the emergency use of the VitalPatch Biosensor when used in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care (not in the intensive care unit) patients who are 18 years of age or older and are undergoing treatment for COVID-19 drugs that can prolong QT intervals and may cause life threatening arrhythmias (e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin). Such remote monitoring may reduce healthcare provider exposure to SARS-CoV-2, the virus that causes COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the U-TOP COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 27, 2020. The U-TOP COVID-19 Detection Kit is authorized for use on using respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Nationwide Children's Hospital 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 , Leber, Amy L., 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 one-page letter authorizes the emergency use of the Biocerna 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 , Sanders, Christopher, 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 LabGun COVID-19 RT-PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 29, 2020. The LabGun COVID-19 RT-PCR Kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Fresenius multiFiltrate PRO System and multiBic/multiPlus Solutions to provide continuous renal replacement therapy to treat patients in an acute care environment during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Altru Dx 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 , Rakhade, Mrudula, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
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: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Bio-Rad SARS-CoV-2 ddPCR Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 1, 2020. The Bio-Rad SARS-CoV-2 ddPCR Testis authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BioFire Respiratory Panel 2.1 (RP2.1), which received an Emergency Use Authorization from the Food and Drug Administration on May 1, 2020. The BioFire RP2.1 test is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a protective barrier enclosure during the COVID-19 pandemic. The virus that causes COVID-19 is highly contagious, and the protective barrier enclosure provides an additional layer of protection when exposure to bodily fluids and airborne particles or droplets from COVID-19 patients are expected.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the VentFree Respiratory Muscle Stimulator, which received an Emergency Use Authorization from the Food and Drug Administration on May 1, 2020, in healthcare settings for treatment of mechanically ventilated adult patients during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the UTHSC/UCH SARS-CoV-2-RT-PCR 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 , Hodge, Tim, 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 FTD SARS-CoV-2 test, which received an Emergency Use Authorization from the Food and Drug Administration on May 5, 2020. The FTD SARS-CoV-2 test is authorized for use on respiratory specimens collected from individuals who are suspected of coronavirus disease 2019 (COVID-19) by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This four-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the PhysiolGuard ECG-QT Analysis System when used in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care (i.e., not in the intensive care unit) patients who are 18 years of age or older and are undergoing treatment for COVID-19 drugs that can prolong QT intervals and may cause life threatening arrhythmias (e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the OPTI SARS-CoV-2 RT PCR Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 6, 2020. The OPTI SARS-CoV-2 RT PCR Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the SARS-COV-2 R-GENE test, which received an Emergency Use Authorization from the Food and Drug Administration on May 6, 2020. The SARS-COV-2 R-GENE test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Sherlock CRISPR SARS-CoV-2 kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 6, 2020. The Sherlock CRISPR SARS-CoV-2 kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 7, 2020. The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay is authorized for use on respiratory specimens from individuals suspected of coronavirus disease 2019 (COVID-19) by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Quick SARS-CoV-2 rRT-PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 7, 2020. The Quick SARS-CoV-2 rRT-PCR Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Patient Isolation Transport Unit (PITU). The PITU is intended for use by healthcare providers (HCP) for temporary isolation and transport of patients with suspected or confirmed diagnosis of COVID-19 requiring airborne or droplet isolation precautions in healthcare settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment (PPE).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Facilities, Prevention and Control/Risk Management, Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheets informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Sofia 2 SARS Antigen FIA test, which received an Emergency Use Authorization from the Food and Drug Administration on May 8, 2020. The Sofia 2 SARS Antigen FIA test is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This nine-page details the Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL, to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit (ICU) setting during the 2019 coronavirus disease (COVID-19) pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Gnomegen COVID-19 RT-qPCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 8, 2020. The Gnomegen COVID-19 RT-qPCR Detection Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Biocollections Worldwide 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
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 providers of the significant known and potential risks and benefits of the emergency use of the Eko ECG Low Ejection Fraction Tool (ELEFT). This software device for diagnosing low Left Ventricular Ejection Fraction (LVEF) is for use by healthcare professionals (HCP) to provide an assessment of LVEF for use as a diagnostic aid to screen for potential cardiac complication associated with COVID-19 or underlying cardiac conditions that may affect clinical management of COVID-19, in adult patients having or suspected of having COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease, Patient Treatment and Experience, Vulnerable Populations, Pre-existing Medical Conditions
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the 1copy COVID-19 qPCR Multi Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 11, 2020. The 1copy COVID-19 qPCR Multi Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Ascom teleCARE IP Nurse Call System. During the COVID-19 outbreak, the remote communication and monitoring capabilities of the teleCARE IP Nurse Call System may reduce the amount of contact by healthcare providers with patients who are in isolation rooms, thereby reducing healthcare provider risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Facilities, Patient Treatment and Experience, Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Abbott Alinity m SARS-CoV-2 assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 11, 2020. The Abbott Alinity m SARS-CoV-2 assay is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Triplex CII-SARS-CoV-2 rRT-PCR Test, 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 , Mishra, Nischay, 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 Linea COVID-19 Assay Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 13, 2020. The Linea COVID-19 Assay Kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test, 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 , Sewell, Brianna, 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 two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of infusion pumps and infusion pump accessories. Certain infusion pumps and infusion pump accessories are authorized for emergency use by healthcare providers to treat conditions caused by the coronavirus disease 2019 (COVID-19) with the controlled infusion of medications, total parenteral nutrition (TPN), and/or other fluids.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Health Facilities
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Aptima SARS-CoV-2 assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 14, 2020. The Aptima SARS-CoV-2 assay is authorized for use on respiratory specimens collected from individuals meeting COVID-19 clinical and/or epidemiological criteria.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the NeoPlex COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 14, 2020. The NeoPlex COVID-19 Detection Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the G Medical VSMS ECG Patch. The VSMS Patch is authorized for emergency use in the hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) in general care (i.e., not in the intensive care unit) patients who are 18 years of age or older and are undergoing treatment for COVID-19 using drugs that can prolong the QT intervals and may cause life-threatening arrhythmias ( e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management, Health Workforce, Health Facilities
Collection: Global Health Events web archive
Description: This 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 three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Fulgent COVID-19 by RT-PCR Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 15, 2020. The Fulgent COVID-19 by RT-PCR Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 infection by their healthcare provider or self-collected using a home collection kit specified in the test's instructions for use.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Assurance SARS-CoV-2 Panel, which received an Emergency Use Authorization from the Food and Drug Administration on May 15, 2020. The Assurance SARS-CoV-2 Panel is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 infection by their healthcare provider or self-collected using a home collection kit specified in the test's instructions for use.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Lyra Direct SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 18, 2020. The Lyra Direct SARS-CoV-2 Assay is authorized for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This 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: 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 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 STEAM Decon Cycle in AMSCO Medium Steam 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.)
Keyword: Prevention and Control/Risk Management, 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 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 three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the P23 Labs TaqPath SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on May 21, 2020. The P23 Labs TaqPath SARS-CoV-2 Assay is authorized for use on respiratory and saliva 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 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 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 eight-page letter of authorization details the Emergency Use Authorization (EUA) issued in response to concerns relating to insufficient supply and availability of gowns and other apparel for use by healthcare personnel (HCP) as personal protective equipment (PPE) for use in healthcare settings in accordance with Centers for Disease Control and Prevention (CDC) recommendations to protect both HCP and patients from the transfer of SARS-CoV-2, which causes COVID-19, in low or minimal risk level situations to prevent the spread of COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Facilities
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Exact Sciences SARS-CoV-2 (N gene detection) test, 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 , Laffin, Jennifer, 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 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 Hymon SARS-CoV-2 Test Kit, which received an Emergency Use Authorization from the Food and Drug Administration on May 22, 2020. The Hymon SARS-CoV-2 Test 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 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 three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LetsGetChecked Coronavirus (COVID-19) Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 28, 2020. The LetsGetChecked Coronavirus (COVID-19) Test is authorized for use on nasal swab specimens self-collected by individuals at home, using the LetsGetChecked COVID-19 Home Collection Kit, when determined by a healthcare provider to be appropriate.
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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 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 one-page letter authorizes the emergency use of the CSI SARS-CoV-2 RT PCR test, 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 , Goudy, Kevin, 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 Gravity Diagnostics COVID-19 Assay. The Gravity Diagnostics COVID-19 Assay is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 infection by their healthcare provider or self-collected using a home collection kit specified in the test's instructions for use.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the 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: 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 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
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 Phosphorus COVID-19 RT-qPCR Test. The Phosphorus COVID-19 RT-qPCR Test is authorized for use on saliva 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: 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 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 Illumina COVIDSeq Test. The Illumina COVIDSeq Test is authorized for use with respiratory specimens collected from individuals who are suspected to have 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 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 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 ExProbe SARS-CoV-2 Testing Kit. The ExProbe SARS-CoV-2 Testing 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 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 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 15-page document provides a memorandum explaining the basis for revocation of the Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate, effective June 15, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Disbrow, Gary L., 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 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 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 informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the KPMAS COVID-19 Test. The KPMAS COVID-19 Test is authorized for use on nasal swab specimens self-collected by individuals at home, using the KPMAS COVID-19 Home Collection Kit, when determined by a healthcare provider to be appropriate.
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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 letter, issued on June 16, 2020, is notification of the revocation of the Emergency Use Authorization for the DPP COVID-19 IgM/IgG System, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Sigismondi, Louise M., 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 three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COVID-19 Coronavirus Real Time PCR Kit. The COVID-19 Coronavirus Real Time PCR Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the OSUWMC (Ohio State University Wexner Medical Center) COVID-19 RT-PCR test for qualitative detection of nucleic acid from SARS-CoV-2 in nasal, oropharyngeal (OP), and nasopharyngeal (NP) swab 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 , Pancholi, Preeti, 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 seven-page letter details the Emergency Use Authorization (EUA) for the Omni COVID-19 Assay by RT-PCR for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage 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 , Kamal, Mohammad, 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 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 seven-page letter, updated on June 22, 2020, authorizes the emergency use of the COVID-19 Airway Management Isolation Chamber. 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 during transport of patients, at the time of definitive airway management, or when performing medical procedures on such patients during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Paxton, Mark S., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
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