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 contract number 75A50121C0, the project has received complete or partial funding from federal sources provided by the Department of Health and Human Services, specifically through the Administration for Strategic Preparedness and Response and BARDA
- Furthermore, the studies funded by BARDA are ongoing to explore more features to support at-home respiratory test
Ref: Prnewswire | Image: Visby Medical
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