Visby Medical™ Submits Men's Sexual Health Test to FDA for Clearance and CLIA Waiver

Visby Medical™ Submits Men's Sexual Health Test to FDA for Clearance and CLIA Waiver

If cleared, Visby Medical's test will provide fast PCR results for Chlamydia and Gonorrhea using male urine samples in diverse clinical settings, meeting clinical demand and established medical guidelines at a time when STIs are a growing threat to public…

Application submitted to FDA for 510(k) clearance of Men’s Sexual Health Test

The single-use test can deliver diagnostic results for chlamydia and gonorrhea in approximately 30 minutes.