- *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, 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.
†Smartphone is not included in the test kit.
‡Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the point of care, ie, in patient care settings operating under a CLIA Certificate of Waiver, CLIA Certificate of Compliance, or CLIA Certificate of Accreditation.