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National Library of Medicine

Archive-It Partner Since: Mar, 2009

Organization Type: National Institutions

Organization URL: http://www.nlm.nih.gov/   

Description:

The National Library of Medicine (NLM), the world's largest medical library and a component of the National Institutes of Health, collects, preserves, and makes available to the public information about health, medicine, and the biomedical sciences. To continue fulfilling this mission, NLM is collecting and archiving related Web content, which also serves to document the histories of health and medicine. For questions about our web archiving program contact us at nlmwebcollecting@nlm.nih.gov.

Page 1 of 1 (63 Total Results)

Title: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests | FDA

URL: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests

Collection: Global Health Events web archive

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Title: Press Announcements | FDA

URL: https://www.fda.gov/news-events/fda-newsroom/press-announcements/

Collection: Global Health Events web archive

Description: Website from U.S. Food and Drug Administration, up to date press announcements

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Title: New York SARS-CoV-2 Real-time RT-PCR Diagnostic Panel

URL: https://www.fda.gov/media/135662/download

Collection: Global Health Events web archive

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Title: Letter of Authorization: Yale New Haven Hospital, Clinical Virology Laboratory, SARS-CoV-2 PCR Test

URL: https://www.fda.gov/media/136601/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Yale New Haven Hospital SARS-CoV-2 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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Title: Letter of Authorization: Viracor SARS-CoV-2 Assay

URL: https://www.fda.gov/media/136739/download

Collection: Global Health Events web archive

Description: This one-page document authorizes the emergency use of the Viracor 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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Title: Letter of Authorization: UNC Health SARS-CoV-2 Real-Time RT-PCR Test

URL: https://www.fda.gov/media/136879/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the UNC Health 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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Title: Letter of Authorization: SDI SARS-CoV-2 Assay, Specialty Diagnostic (SDI) Laboratories

URL: https://www.fda.gov/media/136878/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the SDI 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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Title: Letter of Authorization: SARS-Cov-2 Assay; Northwestern Diagnostic Molecular Laboratory

URL: https://www.fda.gov/media/136658/download

Collection: Global Health Events web archive

Description: This two-page letter authorizes the emergency use of the Northwestern Diagnostic Molecular Laboratory 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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Title: Letter of Authorization: SARS-CoV-2 RT-PCR Test; Infectious Disease Diagnostics Laboratory, Department of Pathology and Laboratory Medicine at the Children's Hospital of Philadelphia

URL: https://www.fda.gov/media/136657/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Infectious Disease Diagnostics Laboratory, Department of Pathology and Laboratory Medicine at the Children's Hospital of Philadelphia SARS-CoV-2 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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Title: Letter of Authorization: SARS-CoV-2 PCR Test, Diatherix Eurofins Laboratory

URL: https://www.fda.gov/media/137256/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Diatherix SARS-CoV-2 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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Title: Letter of Authorization: SARS-CoV-2 Assay, Integrity Laboratories

URL: https://www.fda.gov/media/136941/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Integrity 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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Title: Letter of Authorization: Orig3n 2019 Novel Coronavirus (COVID-19) Test

URL: https://www.fda.gov/media/136874/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Orig3n 2019 Novel Coronavirus (COVID-19) 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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Title: Letter of Authorization: CirrusDx SARS-CoV-2 Assay

URL: https://www.fda.gov/media/137035/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the CirrusDx 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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Title: Letter of Authorization: CDI Enhanced COVID-19 Test, HUMC Molecular Pathology Laboratory

URL: https://www.fda.gov/media/137037/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the CDI Enhanced COVID-19 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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Title: Joint Media Call: FDA & CDC to Discuss Janssen COVID-19 Vaccine - 4/13/2021 - YouTube

URL: https://www.youtube.com/watch?v=_ELXnGYgsJY

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: qSARS-CoV-2 lgG/lgM Rapid Test-Cellex Inc.

URL: https://www.fda.gov/media/136623/download

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 qSARS-CoV-2 lgG/lgM Rapid Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 1, 2020. The qSARS-CoV-2 lgG/lgM Rapid Test is authorized for use on serum, plasma, or venipuncture whole blood specimens from people suspected of Coronavirus Disease 2019 (COVID-19) by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: iAMP COVID-19 Detection Kit - Atila BioSystems, Inc.

URL: https://www.fda.gov/media/136869/download

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 iAMP COVID-19 Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 10, 2020. The iAMP COVID-19 Detection Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: ePlex® SARS-CoV-2 Test; GenMark Diagnostics, Inc.

URL: https://www.fda.gov/media/136281/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: cobas ® SARS-CoV-2

URL: https://www.fda.gov/media/136047/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Xpert® Xpress SARS-CoV-2; Cepheid

URL: https://www.fda.gov/media/136313/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: VITROS Immunodiagnostic Products Anti-SARS-CoV2 Total Reagent Pack Ortho-Clinical Diagnostics, Inc.

URL: https://www.fda.gov/media/136970/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test is authorized for use on serum and EDTA plasma specimens from individuals suspected of coronavirus disease 2019 (COVID-19) by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: TaqPath COVID-19 Combo Kit

URL: https://www.fda.gov/media/136111/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Smart Detect SARS-CoV-2 rRT-PCR Kit - InBios International, Inc.

URL: https://www.fda.gov/media/136785/download

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 Smart Detect SARS-CoV-2 rRT-PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 7, 2020. The Smart Detect SARS-CoV-2 rRT-PCR Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Simplexa COVID-19 Direct Assay; DiaSorin Molecular LLC

URL: https://www.fda.gov/media/136285/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit - ScienCell Research Laboratories

URL: https://www.fda.gov/media/136689/download

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 ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: STANDARD M nCoV Real-Time Detection kit - SD BIOSENSOR, Inc.

URL: https://www.fda.gov/media/137301/download

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 STANDARD M nCoV Real-Time Detection kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 23, 2020. The STANDARD M nCoV Real-Time Detection kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: SARS-CoV-2 Fluorescent PCR Kit - Maccura Biotechnology (USA) LLC

URL: https://www.fda.gov/media/137025/download

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 Fluorescent PCR Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 14, 2020. The SARS-CoV-2 Fluorescent PCR Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare providers.

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Title: Fact Sheet for Healthcare Providers: RealStar® SARS-CoV-2 RT-PCR Kit U.S. - altona Diagnostics GmbH

URL: https://www.fda.gov/media/137251/download

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 RealStar® SARS-CoV-2 RT-PCR Kit U.S., which received an Emergency Use Authorization from the Food and Drug Administration on April 22, 2020. The RealStar® SARS-CoV-2 RT-PCR Kit U.S. is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: QuantiVirus SARS-CoV-2 Test Kit - DiaCarta, Inc.

URL: https://www.fda.gov/media/136807/download

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 Test kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 8, 2020. The QuantiVirus SARS-CoV-2 Test kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: QIAstat-Dx Respiratory SARS-CoV-2 Panel - QIAGEN GmbH

URL: https://www.fda.gov/media/136568/download

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 QIAstat-Dx Respiratory SARS-CoV-2 Panel, which received an Emergency Use Authorization from the Food and Drug Administration on March 30, 2020. The QIAstat-Dx Respiratory SARS-CoV-2 Panel is authorized for use on respiratory specimens collected from patients suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: PhoenixDx® 2019-CoV - Trax Management Services Inc.

URL: https://www.fda.gov/media/137152/download

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® 2019-CoV, which received an Emergency Use Authorization from the Food and Drug Administration on April 20, 2020. The PhoenixDx® 2019-CoV is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: PerkinElmer ® New Coronavirus Nucleic Acid Detection Kit - PerkinElmer Inc.

URL: https://www.fda.gov/media/136408/download

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 PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on March 24, 2020. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Panther Fusion® SARS-CoV-2 - Hologic, Inc.

URL: https://www.fda.gov/media/136154/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: NxTAG® CoV Extended Panel Assay - Luminex Corporation

URL: https://www.fda.gov/media/136498/download

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 NxTAG CoV Extended Panel Assay, which received an Emergency Use Authorization from the Food and Drug Administration on March 27, 2020. The NxTAG CoV Extended Panel Assay is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests

URL: https://www.fda.gov/media/136599/download

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 Laboratory Developed Test (LDT) COVID-19 Authorized Test (Molecular LDT COVID-19 Authorized 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 respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Lyra SARS-CoV-2 Assay; Quidel Corp.

URL: https://www.fda.gov/media/136226/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Logix Smart COVID-19 Kit - Co-Diagnostics, Inc.

URL: https://www.fda.gov/media/136685/download

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 Logix Smart Coronavirus Disease 2019 (COVID-19) kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The Logix Smart COVID-19 kit is authorized for use on using respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: ID NOW COVID-19 - Abbott Diagnostics Scarborough, Inc.

URL: https://www.fda.gov/media/136523/download

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 ID NOW COVID-19, which received an Emergency Use Authorization from the Food and Drug Administration on March 27, 2020. The ID NOW COVID-19 is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Gnomegen COVID-19 RT-Digital PCR Detection Kit - Gnomegen LLC

URL: https://www.fda.gov/media/136736/download

Collection: Global Health Events web archive

Description: This three-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Gnomegen COVID-19 RT-Digital PCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 6, 2020. The Gnomegen COVID-19 RT-Digital PCR Detection Kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: GeneFinder COVID-19 Plus RealAmp Kit - OSANG Healthcare

URL: https://www.fda.gov/media/137114/download

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 GeneFinder COVID-19 Plus RealAmp Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 19, 2020. The GeneFinder COVID-19 Plus RealAmp Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: GSTM COVID-19 RT-PCR KIT - GenoSensor LLC

URL: https://www.fda.gov/media/137091/download

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 GSTM COVID-19 RT-PCR KIT, which received an Emergency Use Authorization from the Food and Drug Administration on April 16, 2020. The GSTM COVID-19 RT-PCR KIT is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Fosun COVID-19 RT-PCR Detection Kit - Fosun Pharma USA Inc.

URL: https://www.fda.gov/media/137118/download

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 Fosun COVID-19 RT-PCR Detection Kit, which received an Emergency Use Authorization from the Food and Drug Administration on April 17, 2020. The Fosun COVID-19 RT-PCR Detection Kit is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Curative-Korva SARS-Cov-2 Assay - KorvaLabs Inc.

URL: https://www.fda.gov/media/137087/download

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 Curative-Korva SARS-Cov-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 16, 2020. The Curative-Korva SARS-Cov-2 Assay is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: COVID-19 ELISA IgG Antibody Test - Mount Sinai

URL: https://www.fda.gov/media/137030/download

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 IgG Antibody Test, which received an Emergency Use Authorization from the Food and Drug Administration on April 15, 2020. The COVID-19 ELISA IgG Antibody Test is authorized for use on serum or plasma specimens from individuals suspected of prior infection with the virus that causes coronavirus disease 2019 (COVID-19) by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: COV-19 IDx Assay- Ipsum Diagnostics, LLC

URL: https://www.fda.gov/media/136619/download

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 COV-19 IDx assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 1, 2020. The COV-19 IDx assay is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: BioGX SARS-CoV-2 Reagents for BD MAX System

URL: https://www.fda.gov/media/136652/download

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 BioGX SARS-CoV-2 Reagents for BD MAX System, which received an Emergency Use Authorization from the Food and Drug Administration on April 2, 2020. The BioGX SARS-CoV-2 Reagents for BD MAX System is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: BioFire® COVID-19 Test - BioFire Defense, LLC

URL: https://www.fda.gov/media/136357/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: BD SARS-CoV-2 Reagents for BD MAX System - BD

URL: https://www.fda.gov/media/136815/download

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 BD SARS-CoV-2 Reagents for BD MAX System, which received an Emergency Use Authorization from the Food and Drug Administration on April 8, 2020. The BD SARS-CoV-2 Reagents for BD MAX System is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: AvellinoCoV2 - Avellino Lab USA, Inc.

URL: https://www.fda.gov/media/136451/download

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 AvellinoCoV2, which received an Emergency Use Authorization from the Food and Drug Administration on March 25, 2020. The AvellinoCoV2 is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Allplex 2019-nCoV Assay - Seegene, Inc

URL: https://www.fda.gov/media/137177/download

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 Allplex 2019-nCoV Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 21, 2020. The Allplex 2019-nCoV Assay is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers: Accula SARS-Cov-2 Test - Mesa Biotech Inc.

URL: https://www.fda.gov/media/136347/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: Abbott RealTime SARS-CoV-2 Assay; Abbott Molecular, Inc.

URL: https://www.fda.gov/media/136256/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Healthcare Providers: ARIES® SARS-CoV-2 Assay - Luminex Corporation

URL: https://www.fda.gov/media/136692/download

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 ARIES® SARS-CoV-2 Assay, which received an Emergency Use Authorization from the Food and Drug Administration on April 3, 2020. The ARIES® SARS-CoV-2 Assay is authorized for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.

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Title: Fact Sheet for Healthcare Providers

URL: https://www.fda.gov/media/134920/download

Collection: Global Health Events web archive

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Title: Fact Sheet for Health Care Professionals: Interpreting CDC Novel Coronavirus 2012 Real-time RT-PCR Assay Test Results | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/fact-sheet-health-care-professionals-interpreting-cdc-novel-coronavirus-2012-real-time-rt-pcr-assay

Collection: Global Health Events web archive

Description: This resource provides information about the Food and Drug Administration (FDA)'s issuance of an Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Novel Coronavirus 2012 Real-time RT-PCR Assay to test for the presumptive presence of Middle East respiratory syndrome coronavirus (MERS-CoV) in the following clinical specimens: upper respiratory specimens, such as nasopharyngeal swabs and oropharyngeal swabs; lower respiratory specimens, such as bronchoalveolar lavage, bronchial wash, tracheal aspirate, and sputum; serum; and stool.

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Title: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory

Collection: Global Health Events web archive

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Title: FDA Briefing Document - Vaccines and Related Biological Products Advisory Committee Meeting

URL: https://www.fda.gov/media/159452/download

Collection: Global Health Events web archive

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Title: Coronavirus Testing Basics | FDA

URL: https://www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics/

Collection: Global Health Events web archive

Description: Website from the US Food and Drug Administration, "Coronavirus Disease 2019 Testing Basics", with information on COVID-19 testing and other resources.

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Title: Coronavirus (COVID-19) and Medical Devices | FDA

URL: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices

Collection: Global Health Events web archive

Description: Website from the U.S. Food and Drug Administration regarding COVID-19 and medical devices, includes information about in vitro diagnostic tests, masks and respirators, PPE, ventilators, and other medical devices.

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Title: Coronavirus (COVID-19) Update: October 26, 2021 | FDA

URL: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-october-26-2021

Collection: Global Health Events web archive

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Title: Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments | FDA

URL: https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments/

Collection: Global Health Events web archive

Description: Website from U.S. Food and Drug Administration regarding fraudulent COVID-19 tests, vaccines and treatments

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URL: https://www.fda.gov/media/157720/download

Collection: Global Health Events web archive

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URL: https://www.fda.gov/media/136471/download

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-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV, which received an Emergency Use Authorization from the Food and Drug Administration on March 26, 2020. The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is authorized for use on using respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

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