Learn more about NeuMoDx at qiagen.com/neumodx

* Mandatory fields

^† Subject to your consent given above, QIAGEN may use your personal information for internal business and marketing purposes. The information will not be sold to any third party. QIAGEN may transfer your personal information to our CRM system (hosted by SalesForce.com, Inc. and Oracle Corp.) solely for the purposes of data hosting, phone calls and QIAGEN email distribution. You may unsubscribe at any time. Your data will be processed in compliance with applicable privacy laws including the EU General Data Protection Regulation All information you provide in this site will be governed by our Privacy Policy.

The NeuMoDxTM Saliva Collection Kit and The NeuMoDxTM SARS-CoV-2 Assay are CE-marked products under the In Vitro Diagnostic Directive.

The NeuMoDxTM Saliva Collection Kit is authorized for Emergency Use Authorization in the United States and is for use only with the NeuMoDx™ SARS-CoV-2 Assay.

• The NeuMoDx™ Saliva Collection Kit has not been FDA cleared or approved.
• The NeuMoDx™ Saliva Collection Kit has been authorized by FDA under an EUA.
• The NeuMoDx™ Saliva Collection Kit has been authorized only to collect, stabilize, and maintain during transport, saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA), not for any other viruses or pathogens.
• This sample collection device is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices during the COVID-19 outbreak under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The NeuMoDxTM SARS-CoV-2 Assay is authorized for Emergency Use Authorization in the United States.

• This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.