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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.

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Title: UCSD RC SARS-CoV-2 Assay - FDA Authorization Letter

URL: https://www.fda.gov/media/140714/download

Collection: Global Health Events web archive

Description: This eight-page letter details the Emergency Use Authorization (EUA) for the UCSD RC SARS-CoV-2 Assay for qualitative detection of nucleic acid from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swab specimens) collected from individuals suspected of COVID-19 by their healthcare provider. This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples.

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