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Collection: Global Health Events web archive
Description: This 10-page Letter of Authorization was updated on June 6, 2020, with five revisions regarding the emergency use of the authorized respirators, as described in the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) of this letter for use in healthcare settings by healthcare providers when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during filtering facepiece respirator shortages resulting from the COVID-19 outbreak.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This nine-page letter, revised on June 6, 2020, updates the April 3, 2020, Emergency Use Authorization for certain product classifications for imported disposable filtering facepiece respirators that are manufactured in China and not approved by the Centers for Disease Control and Prevention's National Institute of Occupational Safety and Health (NIOSH). The Scope of Authorization was revised such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page document authorizes the emergency use of the Stanford SARS-CoV-2 PCR Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Kong, Christina S., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page document, updated on April 24, 2020, details how the emergency use of face masks by the general public and healthcare workers, in accordance with Centers for Disease Control and Prevention recommendations, as personal protective equipment to help prevent spread of the virus during the COVID-19 pandemic meets the criteria for issuance of an Emergency Use Authorization.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the COVID-19 Key Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Sanford, Nicholas, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the UDX SARS-CoV-2 Molecular Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Tab, Sean, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the AIT Laboratories SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Grnager, John K., Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Nationwide Children's Hospital SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Leber, Amy L., Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Biocerna SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Sanders, Christopher, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Altru Dx SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Rakhade, Mrudula, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: The Food and Drug Administration (FDA) updated this Emergency Use Authorization (EUA) on October 1, 2020, to permit the emergency use of the unapproved product remdesivir for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and children hospitalized with severe disease. The FDA approved remdesivir for the treatment of COVID-19 requiring hospitalization on October 22, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Low, Madelyn, O'Shaughnessy, Jacqueline A.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Biomedical Research
Collection: Global Health Events web archive
Description: This 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 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 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 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 seven-page letter details the Emergency Use Authorization for the Everlywell COVID-19 Test Home Collection Kit, which is intended to facilitate self-collection of nasal swab specimens at home by individuals when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Kwo, Liz, Shuren, Jeffery E.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Color SARS-CoV-2 LAMP Diagnostic Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Zhou, Alicia Y., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This eight-page letter of authorization details the Emergency Use Authorization (EUA) issued in response to concerns relating to insufficient supply and availability of gowns and other apparel for use by healthcare personnel (HCP) as personal protective equipment (PPE) for use in healthcare settings in accordance with Centers for Disease Control and Prevention (CDC) recommendations to protect both HCP and patients from the transfer of SARS-CoV-2, which causes COVID-19, in low or minimal risk level situations to prevent the spread of COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Health Facilities
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Exact Sciences SARS-CoV-2 (N gene detection) test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Laffin, Jennifer, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Avera Institute for Human Genetics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Ehli, Erik, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This 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 Warrior Diagnostics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Doss, Megan, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This one-page letter authorizes the emergency use of the Corneum SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Vigerust, David, Scherf, Uwe
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This 15-page document provides a memorandum explaining the basis for revocation of the Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate, effective June 15, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Disbrow, Gary L., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This three-page letter, issued on June 16, 2020, is notification of the revocation of the Emergency Use Authorization for the DPP COVID-19 IgM/IgG System, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Sigismondi, Louise M., Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the OSUWMC (Ohio State University Wexner Medical Center) COVID-19 RT-PCR test for qualitative detection of nucleic acid from SARS-CoV-2 in nasal, oropharyngeal (OP), and nasopharyngeal (NP) swab specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Pancholi, Preeti, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This seven-page letter details the Emergency Use Authorization (EUA) for the Omni COVID-19 Assay by RT-PCR for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Kamal, Mohammad, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This 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 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: 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 seven-page letter details the Emergency Use Authorization (EUA) for the DSL COVID-19 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swabs) and bronchioalveolarlavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration , Hoffman, Tony, Hinton, Denise M.
Language: English
Type: Letter
Collector: National Library of Medicine (U.S.)
Keyword: Basic Information, Biomedical Research
Collection: Global Health Events web archive
Description: This 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 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 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 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 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 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
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