ABSTRACT

Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Helix COVID-19 NGS Test]   [open pdf - 116KB]

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 Helix COVID-19 NGS [next-generation sequencing] Test 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."

Publisher:
Date:
2020?
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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