Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

Shots:The US FDA granted 510(k) clearance (previously granted with EUA in Dec’22) and CLIA waiver for point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid PCR test used to detect and differentiate between upper respiratory infections caused by influenza (Flu) A & B and SARS-CoV-2 (COVID-19) Under the…