ABSTRACT

Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel]   [open pdf - 120KB]

From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular LDT [Laboratory Developed Test] COVID-19 [coronavirus disease 2019] Authorized Test called the UMass [University of Massachusetts] Molecular Virology Laboratory 2019-nCoV rRT-PCR [novel coronavirus real-time reverse transcription polymerase chain reaction] Dx [diagnosis] Panel 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."

Report Number:
Version 2.0
Publisher:
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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