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Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the MassARRAY SARS-CoV-2 Panel. The MassARRAY SARS-CoV-2 Panel is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Sampinute™ COVID-19 Antigen Magnetic Immunoassay (MIA). The Sampinute™ COVID-19 Antigen MIA is authorized for use using nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LumiraDx SARS-CoV-2 RNA STAR Complete. The LumiraDx SARS-CoV-2 RNA STAR Complete is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the CareStart™ COVID-19 Antigen test. The CareStart™ COVID-19 Antigen test is authorized for use using nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ePlex® Respiratory Pathogen Panel 2. The ePlex® Respiratory Pathogen Panel 2 is authorized for use with nasopharyngeal swab specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the UCLA SwabSeq COVID-19 Diagnostic Platform. The UCLA SwabSeq COVID19 Diagnostic Platform is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the AQ-TOP COVID-19 Rapid Detection Kit PLUS. The AQ-TOP COVID-19 Rapid Detection Kit PLUS is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Sofia 2 Flu + SARS Antigen FIA. The Sofia 2 Flu + SARS Antigen FIA is authorized for use with certain respiratory specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the OmniPATH COVID-19 Total Antibody ELISA Test. The OmniPATH COVID-19 Total Antibody ELISA Test is authorized for the detection of total antibodies (including IgM/IgG/IgA) to SARS-CoV-2 in human serum.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ). The BioFire RP2.1-EZ is authorized for use with nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Access IL-6. The Access IL-6 is authorized for use in human serum and plasma specimens collected from patients with confirmed coronavirus disease-2019 (COVID-19) to assist in identifying severe inflammatory response to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Patient Treatment and Experience, Health Facilities
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the iC SARS-CoV2 Test. The iC SARS-CoV2 Test is authorized for use with upper respiratory tract specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Alimetrix SARS-CoV-2 RT-PCR Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit. The Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit is authorized for the detection of antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA and lithium heparin) specimens.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the FREND COVID-19 total Ab. The FREND COVID-19 total Ab is authorized for the qualitative detection of total antibodies to SARS-CoV-2 in human dipotassium EDTA plasma.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the SARS-CoV-2 Mass Array Test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Akron Children's Hospital SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the CentoSure SARS-CoV-2 RT-PCR Assay. The CentoSure SARS-CoV-2 RT-PCR Assay is authorized for use with dry oropharyngeal swab specimens from individuals without symptoms or other reasons to suspect COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Aeon Global Health SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the MosaiQ COVID-19 Antibody Magazine. The MosaiQ COVID-19 Antibody Magazine is authorized for the detection of total (IgM and IgG) antibodies to SARS-CoV-2 in human serum and dipotassium (K2) and tripotassium (K3)EDTA plasma.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Genetrack SARS-CoV-2 Molecular Assay. The Genetrack SARS-CoV-2 Molecular Assay is authorized for use with anterior nasal swab specimens self-collected at home using the Vo' COVID-19 Test Home Collection Kit by individuals suspected of COVID-19 when home collection is determined to be appropriate by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COViage System (or "COViage") for use by healthcare providers in the hospital setting for adult patients (18 years of age or older who are admitted to the hospital) with confirmed COVID-19 (based on a positive PCR test result) for the computation of proprietary patient status indices referred to as Respiratory Decompensation Status and Hemodynamic Instability Status as an adjunct to patient monitoring during the COVID-19 outbreak.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Prevention and Control/Risk Management, Patient Treatment and Experience, Health Facilities
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of COVIAGE. This device is authorized for use by healthcare personnel (HCP) as an extra layer of protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, when performing airway-related medical procedures, or during certain transport of such patients during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce, Prevention and Control/Risk Management, Patient Treatment and Experience
Collection: Global Health Events web archive
Description: This fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Xpert Xpress SARS-CoV-2/Flu/RSV test. The Xpert Xpress SARS-CoV-2/Flu/RSV test is authorized for use with certain respiratory specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Tracking the Disease
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Clear Dx SARS-CoV-2 Test. The Clear Dx SARS-CoV-2 Test is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ViroKey SARS-CoV-2 RT-PCR Test v2.0. The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Clarifi COVID-19 Test Kit. The Clarifi COVID-19 Test Kit is authorized for use with saliva swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the KimForest SARS-CoV-2 Detection Kit v1. The KimForest SARS-CoV-2 Detection Kit v1 is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT. The GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the MAGLUMI 2019-nCoV IgM/IgG. The MAGLUMI 2019-nCoV IgM/IgG is authorized for the detection of antibodies to SARS-CoV-2 in human serum and serum in separating gel tubes (SST).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Visby Medical COVID-19. The Visby Medical COVID-19 is authorized for use with nasopharyngeal, nasal, or mid-turbinate swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. Testing is to be conducted on specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Wantai SARS-CoV-2 RT-PCR Kit. The Wantai SARS-CoV-2 RT-PCR Kit is authorized for use with oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Verily COVID-19 RT-PCR Test. The Verily COVID-19 RT-PCR Test is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the qSanger-COVID-19 Assay. The qSanger-COVID-19 Assay is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the SGTi-flex COVID-19 IgG. The SGTi-flex COVID-19 IgG is authorized for the detection of IgG antibodies to SARS-CoV-2 in human serum, venous whole blood (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA), andplasma (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This four-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the cobas SARS-CoV-2 & Influenza A/B assay. Testing is to be conducted on specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Bio-Speedy Direct RT-qPCR SARS-CoV-2. The Bio-Speedy Direct RT-qPCR SARS-CoV-2 is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Kaira 2019-nCoV Detection Kit. The Kaira 2019-nCoV Detection Kit is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the MobileDetect Bio BCC19 Test Kit. The MobileDetect Bio BCC19 Test Kit is authorized for use with certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COVID-19 ELISA pan-Ig Antibody Test. The COVID-19 ELISA pan-Ig Antibody Test is authorized for the detection of antibodies to SARS-CoV-2 in human serum.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BayCare SARS-CoV-2 RT PCR Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The BayCare SARS-CoV-2 RT PCR Assay is authorized for use on nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the SARS-CoV-2 DETECTR Reagent Kit. The SARS-CoV-2 DETECTR Reagent Kit is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the MiraDx SARS-CoV-2 RT-PCR assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the T2SARS-CoV-2 Panel. The T2SARS-CoV-2 Panel is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the PCL SARS-CoV-2 Real-Time RT-PCR Assay that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the BinaxNOW™ COVID-19 Ag Card. The BinaxNOW™ COVID-19 Ag Card is authorized for use using nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test. The Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test is authorized for the detection of antibodies to SARS-CoV-2 in human serum, plasma (Lithium-Heparin, Sodium-Citrate and Acid Citrate Dextrose (ACD)) and venous whole blood (Lithium-Heparin, Sodium-Citrate and Dipotassium EDTA).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the QDx SARS CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The QDx SARS CoV-2 Assay is authorized for use on nasal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Advanta Dx SARS-CoV-2 RT-PCR Assay. The Advanta Dx SARS-CoV-2 RT-PCR Assay is authorized for use with saliva specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the DxTerity SARS-CoV-2 RT-PCR Test. he DxTerity SARS-CoV-2 RT-PCR Test is authorized for use with saliva specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Guardant-19 test that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This five-page fact sheet provides information for healthcare providers about the Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product COVID-19 convalescent plasma to treat hospitalized patients with COVID-19.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LumiraDx SARS-CoV-2 Antigen (Ag) Test. The LumiraDx SARS-CoV-2 Ag Test is authorized for use using nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 12 days of the onset of symptoms.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the COVID-19 Nucleic Acid RT-PCR Test Kit. The COVID-19 Nucleic Acid RT-PCR Test Kit is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the SalivaDirect assay. The SalivaDirect assay is authorized for use with saliva specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This six-page fact sheet informs healthcare providers about REGIOCIT, which has been authorized for emergency use as a replacement solution in adult patients treated with Continuous Renal Replacement Therapy (CRRT), and for whom RCA is appropriate, during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Pro-AmpRT SARS-CoV-2 Test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the LumiraDx SARS-CoV-2 RNA STAR. The LumiraDx SARS-CoV-2 RNA STAR test is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Biomeme SARS-CoV-2 Real-Time RT-PCR Test. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Prismaflex HF20 Set to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Alpha Genomix TaqPath SARS-CoV-2 Combo Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Solaris Multiplex SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the emergency use of a Molecular LDT COVID-19 Authorized Test called the GWU COVID-19 RT-PCR Test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the ViroKey™ SARS-CoV-2 RT-PCR Test. The ViroKey™ SARS-CoV-2 RT-PCR Test is authorized for use with certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Helix COVID-19 NGS Test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This two-page fact sheet informs healthcare personnel of the significant known and potential risks and benefits of the emergency use of authorized disposable, single-use surgical masks during the COVID-19 pandemic. It is specific to surgical masks that were authorized by the Food and Drug Administration (FDA) under an emergency use authorization (EUA).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Poplar SARS-CoV-2 TMA Pooling assay. The Poplar SARS-CoV-2 TMA Pooling assay is authorized for use with certain respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Cleveland Clinic SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of 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 significant known and potential risks and benefits of the emergency use of the Impella Left Ventricular (LV) Support Systems. The Impella LV Support Systems are authorized for emergency use by healthcare providers (HCP) in the hospital setting for providing temporary LV unloading and support to treat critical care patients with confirmed COVID-19 infection who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and who develop pulmonary edema while on veno-arterial (V-A) ECMO support or late cardiac decompensation from myocarditis while on veno-venous (V-V) ECMO support.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This 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 the CRL Rapid Response test, which includes the DNA Genotek OMNIgene ORAL OM-505 collection device, that has been authorized for emergency use with saliva specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Lilly SARS-CoV-2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This four-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Airway Dome. This device is authorized for use by healthcare providers (HCP) as an extra layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, or when performing airway-related medical procedures, or during certain transport of such patients during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing). The Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) is authorized for use with oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Helix COVID-19 Test that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the QuantiVirus SARS-CoV-2 Multiplex Test Kit. The QuantiVirus SARS-CoV-2 Multiplex Test Kit is authorized for use with upper respiratory specimens and sputum collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Rapid COVID-19 IgM/IgG Combo Test Kit. The Rapid COVID-19 IgM/IgG Combo Test Kit is authorized for detection of IgG and IGM antibodies to SARS-CoV-2 in serum and acid citrate dextrose (ACD) plasma 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: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the OraRisk COVID-19 RT-PCR test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This 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 Boston Heart COVID-19 RT-PCR Test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Quest Diagnostics HA SARS-CoV-2 Assay. The Quest Diagnostics HA SARS-CoV-2 Assay is authorized for use with nasal swab specimens self-collected using a home collection kit under telemedicine supervision for use by individuals suspected of COVID-19 when home collection is determined to be appropriate by a 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 Quest Diagnostics RC SARS-CoV-2 Assay. The Quest Diagnostics RC SARS-CoV-2 Assay is authorized for use with nasal swab specimens self-collected using a home-collection kit under telemedicine supervision for use by individuals suspected of COVID-19 when home collection is determined to be appropriate by a 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 Quest Diagnostics PF SARS-CoV-2 Assay. The Quest Diagnostics PF SARS-CoV-2 Assay is authorized for use with nasal swab specimens self-collected using a home collection kit under telemedicine supervision by individuals suspected of COVID-19 when home collection is determined to be appropriate by a 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 Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette. This test is authorized for the detection of antibodies to SARS-CoV-2 in human serum, plasma (dipotassium EDTA, sodium citrate, sodium heparin) and venous whole blood (dipotassium EDTA, sodium citrate, sodium heparin).
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Compass Laboratory Services SARS-CoV2 Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Compass Laboratory Services SARS-CoV2 Assay is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider or self-collected using a home collection kit specified in the test's labeling.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the 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 the PowerChek 2019-nCoV Real-time PCR Kit. The PowerChek 2019-nCoV Real-time PCR Kit is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the BMC-CReM COVID-19 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 four-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the gammaCore Sapphire CV during the coronavirus disease 2019 (COVID-19) pandemic. The gammaCore Sapphire CV is intended for acute use at home or in healthcare settings to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using non-invasive vagus nerve stimulation (VNS) on either side of the patient's neck during the COVID-19 pandemic.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Real-Q 2019-nCoV Detection Kit. The Real-Q 2019-nCoV Detection Kit is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the SARS-CoV-2 RNA DETECTR Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of a Molecular LDT COVID-19 Authorized Test called the Gene By Gene SARS-CoV-2 Detection Test that has been issued an Emergency Use Authorization (EUA) by the FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the CareStart COVID-19 MDx RT-PCR test. The CareStart COVID-19 MDx RT-PCR test is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
Collection: Global Health Events web archive
Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the AMPIPROBE SARS-CoV-2 Test System. The AMPIPROBE SARS-CoV-2 Test System is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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Group: Coronavirus disease (COVID-19) outbreak
Creator: United States Food and Drug Administration
Language: English
Type: Fact sheet
Collector: National Library of Medicine (U.S.)
Keyword: Health Workforce
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