Coronavirus Disease 2019 (COVID-19)
Frequently Asked Patient Questions
Bako Diagnostics understands the importance our lab plays in the safety of the public, patients, healthcare providers and our employees.
This page offers answers to frequently asked patient questions. You can also view our Fact Sheet for Patients.
COVID-19 Test Statements:
This test has been authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use by authorized laboratories, such as BakoDx.
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogen.
This test 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.