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NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing high throughput testing solutions to hospital and commercial reference laboratories, has been issued by the U.S. Food and Drug Administration (FDA) an Emergency Use Authorization (EUA) for the NeuMoDx™ SARS-CoV-2 Assay implemented on the NeuMoDx™ Molecular Systems.

The NeuMoDx™ SARS-CoV-2 Assay is a rapid, automated in vitro real-time RT-PCR 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 infection of COVID-19. This multiplexed assay detects highly conserved regions of two SARS-Cov-2 genes, the Nsp2 geneand N gene, and uses different fluorophores for reporting each target.

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NEUMODX SARS-COV-2 ASSAY

 


Fact Sheet for Healthcare Providers
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Fact Sheet for Patients
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FDA Notification
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FDA Notification, EUA Amendment 04232020
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Contact Details

Please provide the following information for the person who experienced the issue:

General Information

DeathSerious adverse eventAdverse event (not serious)Product Problem (defects/malfunctions)Out of service/safety issueProduct use errorLabeling issue
 
 
Initial use of assayRe-use of of instrumentRe-serviced/refurbishedProblem noted prior useDuplicate issueOther (please specify)
TreatmentEvaluation
False negative resultIncorrect qualification of the infection/Unclear resultsFalse positive resultDelayed reporting of resultsOther, please specify

If available, email to: techsupport@neumodx.com (Include compliant in the subject line)

Product Details

Assay, Reagents and Consumables

Instruments

Action Taken


Coronavirus Assay Information

NeuMoDx™ Molecular, a sample-to-result molecular diagnostic company focused on providing testing solutions to hospital and commercial reference laboratories, has developed a SARS-CoV-2 Assay for use on the high throughput, fully automated NeuMoDx™ 288 and 96 Molecular Systems. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the NeuMoDx™ SARS-CoV-2 Assay implemented on the NeuMoDx™ Molecular Systems.

To learn more about SARS-CoV-2 testing, click here.
To order, click here.