The Syphilis Health Check test manufactured by VEDALAB has been granted by FDA on December 15th, 2014 the first-ever CLIA Waiver for a rapid screening test for syphilis. The test can be distributed to non-traditional laboratory sites, including providers’ offices, emergency rooms, maternity wards, and other healthcare facilities.
The waiver also allows untrained health-care workers to perform the tests on patients. The test is manufactured for Diagnostics Direct, LLC, based in Stone Harbor, New Jersey and is also distributed by Mc Kesson Corp. and Trinity Biotech USA, Inc.