The FDA's Experience with Covid-19 Antibody Tests.

Shuren, Jeffrey; Stenzel, Timothy

Shuren, Jeffrey; Stenzel, Timothy.

Shuren J; From the Food and Drug Administration, Silver Spring, MD.
Stenzel T; From the Food and Drug Administration, Silver Spring, MD.

N Engl J Med ; 384(7): 592-594, 2021 02 18.

Article in English | MEDLINE | ID: covidwho-1087543

Subject(s)

COVID-19 Serological Testing/standards; Diagnostic Test Approval; Government Regulation; Marketing of Health Services/legislation & jurisprudence; United States Food and Drug Administration; Clinical Laboratory Techniques/standards; Diagnostic Test Approval/legislation & jurisprudence; Federal Government; Humans; Laboratories/legislation & jurisprudence; Laboratories/standards; Organizational Policy; United States; United States Food and Drug Administration/organization & administration

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Full text: Available Collection: International databases Database: MEDLINE Main subject: United States Food and Drug Administration / Marketing of Health Services / Government Regulation / Diagnostic Test Approval / COVID-19 Serological Testing Type of study: Diagnostic study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Journal: N Engl J Med Year: 2021 Document Type: Article Affiliation country: NEJMp2033687

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