GenBody COVID-19 Ag for the Detection of SARS-CoV-2 Antigen

The GenBody COVID-19 Rapid Antigen Test is subject to an Emergency Use Authorization issued by the Food And Drug Administration. As the product is Authorized for point-of-care use in patient care settings, the tests do not need to be performed at a laboratory. Pursuant to the EUA, however, the testing of specimens using the Product must be performed by an entity certified under the Clinical Laboratory improvement “CLIA” which meets certain requirements. To use the Product, therefore, the buyer has responsibility to ensure that it has the requisite CLIA Certification, or alternatively work with a third-party that has the requisite CLIA Certification (to provide the tests by its qualified and authorized healthcare professionals at the preferred point-of-care site.