Visby Medical

Visby Medical is a diagnostics company founded in 2012 under the name Click Diagnostics and renamed in 2020, headquartered in San Jose, California, United States. The company builds instrument-free, single-use PCR devices that detect infectious diseases at the point of care.

The palm-sized device requires under 15 seconds of hands-on time and delivers results in under 30 minutes without external lab instruments. Its Respiratory Health Test detects and differentiates COVID-19 and influenza A/B, and a Sexual Health Test line addresses point-of-care STI detection. The products hold FDA 510(k) clearance and Emergency Use Authorization and are designed for CLIA-waived settings such as clinics and pharmacies.

1. Instrument-Free PCR: The single-use device performs PCR testing without external lab equipment.

2. Rapid Turnaround: Results are delivered in under 30 minutes with under 15 seconds of hands-on time.

3. Respiratory Panel: The Respiratory Health Test differentiates COVID-19 from influenza A and B.

4. Sexual Health Testing: A separate product line targets point-of-care STI detection.

5. Regulatory Clearance: Products hold FDA 510(k) clearance and Emergency Use Authorization.

6. CLIA-Waived Deployment: The device is designed for use in CLIA-waived settings such as clinics and pharmacies.