Visby gets FDA clearance, CLIA waiver for POC STI test
Aug. 30, 2021—Visby Medical announced it has received FDA 510(k) clearance and was granted a CLIA waiver to market its single-use PCR diagnostic test for the multiplexed detection of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using a self-collected vaginal swab.