FDA Authorizes Empire City Laboratories’ COVID-19 Test for Emergency Use
Empire City Laboratories (ECL) has received the FDA’s Emergency Use Authorization for its ECL COVID Test System-1.
The system, which analyzes nasal swab samples self-collected at home, includes a cardboard shipping box, a mailing bag with label and shipping instructions. The samples must be from individuals 18 years of age or older suspected of COVID-19 based on the results of an online COVID-19 questionnaire.
The FDA has only authorized the test for use at Empire City Laboratories’ facility in Brooklyn, N.Y.