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# EUA for NeuMoDx Covid-19 Assay
- URL: https://www.fdaweb.com/eua-for-neumodx-covid-19-assay/
- Published: 2020-03-31T12:00:00.000Z
- Updated: 2026-09-14T16:09:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146466

FDA has issued an emergency use authorization for the NeoMoDx SARS-CoV-2 assay running on the NeuMoDx molecular systems. The company [says](https://www.neumodx.com/neumodx-announces-us-fda-emergency-use-authorization-eua-for-sars-cov2-test/?ref=fdaweb.com) the assay is a rapid, automated, *in vitro* real-time diagnostic test for the direct detection of SARS-CoV-2 coronavirus RNA from nasopharyngeal, oropharyngeal, and nasal swab specimens in transport medium from individuals with signs and symptoms of Covid-19 infection. The test generates results in about 80 minutes, the company says.

The assay is said to be available to CLIA-certified hospitals and reference laboratories with experience performing high complexity tests.