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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 (24 Total Results)

Title: : EUA200306 Trade/Device Name: Warrior Diagnostics SARS-CoV-2 Assay - FDA Authorization Letter, : EUA200306 Trade/Device Name: Warrior Diagnostics SARS-CoV-2 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/138791/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Warrior Diagnostics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Avera Institute for Human Genetics SARS-CoV-2 Assay - Letter Granting Inclusion Under EUA

URL: https://www.fda.gov/media/138331/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Avera Institute for Human Genetics SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: COVID-19 Key FDA Authorization Letter

URL: https://www.fda.gov/media/137369/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the COVID-19 Key Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: EUA200187 Trade/Device Name: Cormeum SARS-CoV-2 Assay - FDA Authorization Letter, EUA200187 Trade/Device Name: Cormeum SARS-CoV-2 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/138933/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Corneum SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200013 Trade/Device Name: One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test Laboratory: One Health Laboratories, LLC

URL: https://www.fda.gov/media/138062/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200123 Trade/Device Name: Altru Dx SARS-CoV-2 Assay Laboratory: Altru Diagnostics, Inc.

URL: https://www.fda.gov/media/137545/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Altru Dx SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200171 Trade/Device Name: SAR-Co-V-2 Assay Laboratory: Biocerna

URL: https://www.fda.gov/media/137451/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Biocerna SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200338 Trade/Device Name: UTHSC/UCH SARS-CoV-2-RT-PCR Assay Laboratory: UTMG Pathology Laboratory

URL: https://www.fda.gov/media/137654/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the UTHSC/UCH SARS-CoV-2-RT-PCR Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200360 Trade/Device Name: SARS-CoV-2 Assay Laboratory: Nationwide Children’s Hospital

URL: https://www.fda.gov/media/137424/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Nationwide Children's Hospital SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200425 Trade/Device Name: CSI SARS-CoV-2 RT PCR Test Laboratory: CSI Laboratories

URL: https://www.fda.gov/media/138529/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the CSI SARS-CoV-2 RT PCR test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: Letter Re: EUA200510 Trade/Device Name: Triplex CII-SARS-CoV-2 rRT-PCR Test Laboratory: Columbia University Laboratory of Personalized Genomic Medicine

URL: https://www.fda.gov/media/137982/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the Triplex CII-SARS-CoV-2 rRT-PCR Test, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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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: 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: 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: 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: 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 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 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: 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: 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: 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: 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: SARS-CoV-2 Assay FDA Authorization Letter

URL: https://www.fda.gov/media/137373/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the AIT Laboratories SARS-CoV-2 Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Title: UDX SARS-CoV-2 Molecular Assay FDA Authorization Letter

URL: https://www.fda.gov/media/137371/download

Collection: Global Health Events web archive

Description: This one-page letter authorizes the emergency use of the UDX SARS-CoV-2 Molecular Assay, which is eligible for authorization under the March 31, 2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test).

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Page 1 of 1 (24 Total Results)