COVID-19 Test Statements:
The BakoID COVID test was developed at BakoDx and validated using clinical samples. All validation studies were performed in accordance with the USFDA’s Guidance Document (Policy for Diagnostics Tests Coronavirus Disease-2019 during the Public Health Emergency) issued on February 29th, 2020. This test and its characteristics were initially submitted to USFDA on 4/20/2020 for review. BakoDx is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. This test should not be regarded as investigational or limited to research, but it has not been cleared or approved by the FDA.