EUA granted for NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay
Detect SARS-CoV-2 and 3 other pathogens with one NeuMoDx test.
As COVID-19 continues to affect our everyday lives, it becomes more critical for patients to know if they are infected with SARS-CoV-2 or a different pathogen.
Learn more about NeuMoDx — a revolutionary molecular diagnostic solution
Critical decisions for patient care are dependent on accurate and timely clinical laboratory results. To meet this demand, your lab needs full automation, faster turnaround times, scalability, and streamlined workflows. NeuMoDx systems address these needs – and more.
Product availability may vary by country specific regulatory requirements and approvals. Contact your country representative for further details.
The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay is intended for in vitro diagnostic use.
In the United States:
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.
This product 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 product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and/or Respiratory Syncytial Virus, not for any other viruses or pathogens; and
The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Intuitive 3-step workflow
True random access
IVD & LDT in parallel
High throughput
Ultra-fast insights
No reagent reconstitution
