Emergency Use Authorization (EUA) Disclaimer
© 2021 Luminostics, Inc. dba Clip Health In the USA, the Clip COVID Rapid Antigen Test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for emergency use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests. This test is for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. In the USA, the emergency use of 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 the virus that causes 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.