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Additional Information
This product has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use in vitro diagnostics for the detection and/or diagnosis of COVID-19 under section 564 (b)(1) of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
COVID-19 self-testing kits are not eligible for refunds. Failure to follow all instructions carefully could lead to inconclusive results or voided tests.
StemExpress is the leading global provider of human-derived biological products and services for biomedical research, drug discovery, process development, and cell and gene therapy companies. Through the company's FDA-registered GMP/GTP-compliant collection centers, StemExpress delivers the highest quality products and services to scientists and clinicians across the world.