FDA EMERGENCY USE AUTHORIZATION

Healthcare Strategy Partners offers this test and collection kit with an FDA Emergency Use Authorization. This means that while the laboratory performing this test has validation data to support offering this test and the collection kit, neither have been approved or cleared by the FDA. This test has only been authorized by FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. It is only authorized during the duration of the COVID-19 emergency declaration by federal regulators. Our Lab partner may modify or cease to offer the test and the test kit upon direction of state or federal regulators in its sole discretion.