RE:rom Abbott's siteTHESE ARE THE RESTRICTIONS TO THEIR APPROVAL. I AM SURE THERE WILL BE SOME THAT COME WITH SONA APPROVAL;
*The BinaxNOW™ COVID-19 Ag Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
**Refer to the product package insert for full instructions and clinical data.
† Before testing patients, federal regulations require testing sites to have a CLIA certificate issued by CMS. Sites performing only waived tests must obtain a Certificate of Waiver by applying for this certification for each location performing testing. Learn more about CLIA