Now Available: High Throughput SARS-CoV-2 Ag (CoVAg) Assay1
Improve your confidence in SARS-CoV-2 mass screening with a high-throughput, central lab-based antigen assay that can quickly confirm accurate results in at-risk individuals, including asymptomatic and early-disease patients.
Rapid and accurate testing on a massive scale is vital to address the challenges of the COVID-19 pandemic.
Siemens Healthineers continues to deliver high-value COVID-19 care across disciplines throughout the patient care pathway.
As society continues to navigate through the COVID-19 pandemic, there is a critical public health need to get ahead of the spread with a fast and simple test for all.
This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements.
* These SARS-CoV-2 molecular and serology tests have not been FDA cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. The molecular test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The serology test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. These tests are 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 authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.
** Not available for sale in the U.S. Product availability may vary by country.