ABSTRACT
Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Helix COVID-19 Test] [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 Helix COVID-19 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."
| Report Number: | Version 2.0 |
| Publisher: | |
| Date: | 2020-07-24? |
| Series: | |
| Copyright: | Public Domain |
| Retrieved From: | U.S. Food and Drug Administration: https://www.fda.gov/ |
| Format: | pdf |
| Media Type: | application/pdf |
| URL: |