Artist: Please move the following copy to the beginning of the Note field, directly below the last item code, and remove the italics. Copy won't fit into field in Stibo:
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. “Authorized Laboratories” means (i) for testing of nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, oropharyngeal swab or nasal wash/aspirate specimens using the Test Kits run on the GeneXpert Dx and GeneXpert Infinity systems, laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform high or moderate complexity tests; and (ii) for testing of nasopharyngeal swab, anterior nasal swab or mid-turbinate nasal swab specimens using the Xpert Xpress CoV-2 plus test run on the GeneXpert Xpress System (Tablet and Hub Configurations), laboratories certified under CLIA that meet requirements to perform high, moderate, or waived complexity tests. Testing of these specimens is authorized 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.