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Collection: Global Health Events web archive
Description: This web page, updated on July 2, 2020, provides information about routine screening measures that are already in place for evaluating clinical evidence of infection in human cell, tissue, or cellular or tissue-based product (HCT/P) donors. To date, there have been no reported cases of transmission of COVID-19 via these products. FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors.
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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: Biomedical Research
Collection: Global Health Events web archive
Description: Website from Food and Drug Administration regarding investigational COVID-19 convalescent plasma
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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 20-page guidance, updated on May 11, 2020, provides a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the 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: Health Policy Advocacy, Basic Information
Collection: Global Health Events web archive
Description: This 17-page guidance, updated on September 2, 2020, provides recommendations to healthcare providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.
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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: Basic Information
Collection: Global Health Events web archive
Description: This eight-page guidance was issued to provide recommendations regarding the key factors and procedures that institutional review boards (IRBs) should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Center for Drug Evaluation and Research (U.S.)
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) has issued this 35-page guidance, updated on September 21, 2020, to provide general considerations to assist sponsors in assuring the safety of trial participants in the conduct of clinical trials of medical products, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 (coronavirus) pandemic.
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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.), Center for Devices and Radiological Health, Center for Drug Evaluation and Research
Language: English
Type: Publication
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
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 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: 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: 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: 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: 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 58-minute speech discusses COVID-19, the Food and Drug Administration's role in responding to this public health emergency, and the continuing challenges the agency and the medical profession face as it continues to evolve.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hahn, Stephen M.
Language: English
Type: Video recording
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: "FDA Provides Update on Agency Response to Monkeypox Outbreak"
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Group: Mpox (monkeypox) outbreak 2022
Creator: United States Food and Drug Administration
Language: English
Type: Press release
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information
Collection: Global Health Events web archive
Description: This letter alerts health care providers (HCP) and health care facilities that the use of passive protective barrier enclosures (those without negative pressure) when treating patients who are known or suspected to have coronavirus disease 2019 (COVID-19) may pose an increased health risk to patients and HCPs, and provides recommendations.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Division of Industry and Consumer Education
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
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: 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: Website from the Food and Drug Administration with information regarding ventilators and ventilator accessories EUAs; information about authorized ventilators
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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 from Food and Drug Administration regarding PPE
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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, Health Workforce, Health Facilities
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: Website from Food and Drug Administration regarding the registration and listing of medical devices
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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, Health Facilities
Collection: Global Health Events web archive
Description: Website from Food and Drug Administration with information about sample and screen testing for 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 from Food and Drug Administration regarding medical gloves
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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 from Food and Drug Administration regarding importing medical devices
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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, Health Facilities
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 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 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 letter authorizes the emergency use of the binx health At-Home Nasal Swab COVID-19 Sample Collection Kit. The kit is for use by individuals for self-collection of nasal swab specimens 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 an in vitro diagnostic (IVD) molecular test for the detection of SARS-CoV-2 RNA that is indicated for use with the binx health At-Home Nasal Swab COVID-19 Sample Collection Kit.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Jones, Marc, 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 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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LumiraDx SARS-CoV-2 RNA STAR Complete. The LumiraDx SARS-CoV-2 RNA STAR Complete 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 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 three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ePlex® Respiratory Pathogen Panel 2. The ePlex® Respiratory Pathogen Panel 2 is authorized for use with nasopharyngeal swab 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: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the UCLA SwabSeq COVID-19 Diagnostic Platform. The UCLA SwabSeq COVID19 Diagnostic Platform 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: 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 Rapid Detection Kit PLUS. The AQ-TOP COVID-19 Rapid Detection Kit PLUS 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 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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Sofia 2 Flu + SARS Antigen FIA. The Sofia 2 Flu + SARS Antigen FIA is authorized for use with certain respiratory specimens collected from individuals suspected of respiratory viral infection consistent with 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 OmniPATH COVID-19 Total Antibody ELISA Test. The OmniPATH COVID-19 Total Antibody ELISA Test is authorized for the detection of total antibodies (including IgM/IgG/IgA) to SARS-CoV-2 in 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: 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 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 UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel 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 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 iC SARS-CoV2 Test. The iC SARS-CoV2 Test is authorized for use with upper respiratory tract 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 fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit. The Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit is authorized for the detection of antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA and lithium heparin) specimens.
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Group: Coronavirus 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 FREND COVID-19 total Ab. The FREND COVID-19 total Ab is authorized for the qualitative detection of total antibodies to SARS-CoV-2 in human dipotassium EDTA plasma.
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Group: Coronavirus 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 SARS-CoV-2 Mass Array 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: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Akron Children's Hospital 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: 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 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 Aeon Global Health 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: 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 MosaiQ COVID-19 Antibody Magazine. The MosaiQ COVID-19 Antibody Magazine is authorized for the detection of total (IgM and IgG) antibodies to SARS-CoV-2 in human serum and dipotassium (K2) and tripotassium (K3)EDTA plasma.
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Group: Coronavirus 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 Genetrack SARS-CoV-2 Molecular Assay. The Genetrack SARS-CoV-2 Molecular Assay is authorized for use with anterior nasal swab specimens self-collected at home using the Vo' COVID-19 Test Home Collection Kit by individuals suspected of COVID-19 when home collection is determined to be appropriate 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 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 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: 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 five-page document describes four lines of evidence that continue to support the emergency use of COVID-19 Convalescent Plasma at this time, one month after initial issuance of the Emergency Use Authorization: 1) historical data regarding prior experience with the use of convalescent plasma in other outbreak settings; 2) data from animal studies; 3) data that continues to emerge in the published literature from clinical studies performed during the current outbreak; and 4) results obtained from a large expanded access treatment protocol (National Expanded Program).
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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: 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 ViroKey SARS-CoV-2 RT-PCR Test v2.0. The ViroKey SARS-CoV-2 RT-PCR Test v2.0 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 Clarifi COVID-19 Test Kit. The Clarifi COVID-19 Test Kit is authorized for use with saliva 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 KimForest SARS-CoV-2 Detection Kit v1. The KimForest SARS-CoV-2 Detection Kit v1 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 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 MAGLUMI 2019-nCoV IgM/IgG. The MAGLUMI 2019-nCoV IgM/IgG is authorized for the detection of antibodies to SARS-CoV-2 in human serum and serum in separating gel tubes (SST).
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Group: Coronavirus 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 Visby Medical COVID-19. The Visby Medical COVID-19 is authorized for use with nasopharyngeal, nasal, or 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 cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. 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 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 Verily COVID-19 RT-PCR Test. The Verily COVID-19 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 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 SGTi-flex COVID-19 IgG. The SGTi-flex COVID-19 IgG is authorized for the detection of IgG antibodies to SARS-CoV-2 in human serum, venous whole blood (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA), andplasma (sodium heparin, lithium heparin, sodium citrate and tripotassium 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 four-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the cobas SARS-CoV-2 & Influenza A/B assay. Testing is to be conducted on specimens 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: 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 Kaira 2019-nCoV Detection Kit. The Kaira 2019-nCoV Detection 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 MobileDetect Bio BCC19 Test Kit. The MobileDetect Bio BCC19 Test Kit is authorized for use with 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 COVID-19 ELISA pan-Ig Antibody Test. The COVID-19 ELISA pan-Ig Antibody Test is authorized for the detection of antibodies to SARS-CoV-2 in 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 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 SARS-CoV-2 DETECTR Reagent Kit. The SARS-CoV-2 DETECTR Reagent 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 a Molecular LDT COVID-19 Authorized Test called the MiraDx 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: 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 T2SARS-CoV-2 Panel. The T2SARS-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: 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 PCL SARS-CoV-2 Real-Time RT-PCR Assay that has been issued an Emergency Use Authorization (EUA) by 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 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 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 QDx SARS CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The QDx SARS CoV-2 Assay is authorized for use on nasal 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 Advanta Dx SARS-CoV-2 RT-PCR Assay. The Advanta Dx SARS-CoV-2 RT-PCR Assay 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 a Molecular LDT COVID-19 Authorized Test called the Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by 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 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 a Molecular LDT COVID-19 Authorized Test called the Guardant-19 test that has been issued an Emergency Use Authorization (EUA) by 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 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: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LumiraDx SARS-CoV-2 Antigen (Ag) Test. The LumiraDx SARS-CoV-2 Ag Test is authorized for use using nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 12 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 COVID-19 Nucleic Acid RT-PCR Test Kit. The COVID-19 Nucleic Acid RT-PCR Test 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 SalivaDirect assay. The SalivaDirect assay 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 six-page fact sheet informs healthcare providers about REGIOCIT, which has been authorized for emergency use as a replacement solution in adult patients treated with Continuous Renal Replacement Therapy (CRRT), and for whom RCA is appropriate, 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 a Molecular LDT COVID-19 Authorized Test called the Pro-AmpRT SARS-CoV-2 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 LumiraDx SARS-CoV-2 RNA STAR. The LumiraDx SARS-CoV-2 RNA STAR 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 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 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 a Molecular LDT COVID-19 Authorized Test called the Alpha Genomix TaqPath SARS-CoV-2 Combo 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 emergency use of a Molecular LDT COVID-19 Authorized Test called the Solaris Multiplex 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 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 ViroKey™ SARS-CoV-2 RT-PCR Test. The ViroKey™ SARS-CoV-2 RT-PCR Test is authorized for use with 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 a Molecular LDT COVID-19 Authorized Test called the Helix COVID-19 NGS 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 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 Poplar SARS-CoV-2 TMA Pooling assay. The Poplar SARS-CoV-2 TMA Pooling assay is authorized for use with certain 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 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
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