Disclaimer:  Conditions Related to Advertising and Promotion

A. All descriptive printed matter, advertising, and promotional materials relating to the use of your product shall be consistent with the authorized labeling, as well as the terms set forth in this EUA and meet the requirements set forth in section 502(a), (q)(1), and (r) of the Act and FDA implementing regulations.
B. No descriptive printed matter, advertising, or promotional materials relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.
C. All descriptive printed matter, advertising, and promotional materials relating to the use of your product shall clearly and conspicuously state that:

  • This product has not been FDA cleared or approved;
  • This product has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
  • This product has been authorized only for detecting the presence of IgM and IgG antibodies to SARS-CoV-2, not for any other viruses or pathogens.
  • 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

D. The emergency use of this product as described in the letter of authorization must comply with the conditions and all other terms of this authorization.