*This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
SEKISUI Diagnostics reserves the right to change, modify, or discontinue this promotion at its discretion. Please note that the value of the special offer(s) the Customer may receive from the manufacturer under this program is a discount or other reduction in price to Customer under Section 1128B(b)(3)(A) of the Social Security Act (42 U.S.C. 1320a-7b(b)(3)(a)) and 42 C.F.R. 1001.952(h). Accordingly, Customer shall disclose this and any other discounts or other reductions in price received under this program under any state or federal program which provides cost or charge-based reimbursement to the Customer for the products and services purchased under this program. Valid for U.S. end users only, excluding Puerto Rico.