Visby Medical Gets the FDA’s 510(k) Clearance for PCR Sexual Health Test

September 1, 2021

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.

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