Visby Medical has received 510(k) clearance for its sexual health test, a second-generation polymerase chain reaction (PCR) diagnostic that uses a self-collected vaginal swab to detect three common sexually transmitted infections (STIs) – chlamydia, gonorrhea, and trichomoniasis.
The San Jose, CA-based medtech company also received a CLIA waiver for the test, which the FDA grants to diagnostics with little to no risk, such as cholesterol or pregnancy...
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