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Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the 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 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 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: 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: 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: 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 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 eight-page letter details the Emergency Use Authorization (EUA) for the UCSD RC SARS-CoV-2 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swab specimens) collected from individuals suspected of COVID-19 by their healthcare provider. This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Pride, David T., 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 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 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 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: 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 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 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 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 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 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 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 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 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 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: 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 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 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 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 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 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: 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 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: 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: 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 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 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 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 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 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 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 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 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 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 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: 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: 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 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 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 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 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 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 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 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 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 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 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: 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 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 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 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 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 seven-page letter authorizes the use of this home collection kit by individuals to self-collect nasal swab specimens at home, video-observed by a heathcare provider, when determined by a healthcare provider to be appropriate based on results of a 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 Kroger Health COVID-19 Test Home Collection Kit.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Kirby, Jim, 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 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: 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: This seven-page letter details the Emergency Use Authorization (EUA) for the Inform Diagnostics SARS-CoV-2 RT-PCR Assay for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Wang, Yun, 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 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: 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: This seven-page letter details the Emergency Use Authorization (EUA) for the HealthQuest Esoterics TaqPath SARS-CoV-2 Assay 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 , White, Jerry, 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 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 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 two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Fresenius multiFiltrate PRO System and multiBic/multiPlus Solutions to provide continuous renal replacement therapy to treat patients in an acute care environment during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the 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 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 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 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 three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the G Medical VSMS ECG Patch. The VSMS Patch is authorized for emergency use in the hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) in general care (i.e., not in the intensive care unit) patients who are 18 years of age or older and are undergoing treatment for COVID-19 using drugs that can prolong the QT intervals and may cause life-threatening arrhythmias ( e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Prevention and Control/Risk Management, Health Workforce, Health Facilities
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Fulgent COVID-19 by RT-PCR Test, which received an Emergency Use Authorization from the Food and Drug Administration on May 15, 2020. The Fulgent COVID-19 by RT-PCR Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 infection by their healthcare provider or self-collected using a home collection kit specified in the test's instructions for use.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This 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 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 seven-page letter details the Emergency Use Authorization (EUA) for the FRL SARS CoV-2 Test 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 , Leal, Sixto M. Jr., 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: "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: 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: 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: 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
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 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 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 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 Test Kit (Real-time PCR). The SARS-CoV-2 Test Kit (Real-time PCR) 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 Wren Laboratories COVID-19 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 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 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 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 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 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 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 PhoenixDx SARS-CoV-2 Multiplex. The PhoenixDx SARS-CoV-2 Multiplex 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 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 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 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 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 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
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