ABSTRACT
Fact Sheet for Healthcare Providers: LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel [open pdf - 104KB]
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 LifeHope 2019-nCoV [novel coronavirus] Real-Time RT-PCR [reverse transcription polymerase chain reaction] Diagnostic 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."
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| Copyright: | Public Domain |
| Retrieved From: | U.S. Food and Drug Administration: https://www.fda.gov/ |
| Format: | pdf |
| Media Type: | application/pdf |
| URL: |