![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Visby Medical Gets the FDA’s 510(k) Clearance for PCR Sexual Health Test
Visby Medical Gets the FDA’s 510(k) Clearance for PCR Sexual Health Test
San Jose, Calif.-based Visby Medical’s Sexual Health Click Test has received a 510(k) marketing clearance from the FDA.
The single-use polymerase chain-reaction diagnostic test is designed to detect sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis.
The test, which requires no additional instruments, analyzes self-collected vaginal swab samples in less than 30 minutes in the healthcare provider’s office, according to the company.
Upcoming Events
-
21Oct