*Alliance application manufactured and distributed by Siemens Healthcare Diagnostics Inc.
†Alliance application manufactured by third party, distributed by Siemens Healthcare Diagnostics Inc.
‡Under FDA review. Not available for sale in the U.S.
§Under development. Not commercially available. Future availability cannot be guaranteed.
**CA 125II, CA 15-3, CA 19-9, and CYFRA 21-1 are trademarks of Fujirebio Diagnostics, Inc.
§§This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. 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 authorization is terminated or revoked sooner. Product availability may vary by country and is subject to varying regulatory requirements.