Co-Diagnostics Submits FDA Application For 510(k) Clearance Of Co-Dx PCR Pro Instrument And OTC COVID-19 Test; POC Clearance And Additional Tests To Follow
Portfolio Pulse from Benzinga Newsdesk
Co-Diagnostics has submitted an FDA application for 510(k) clearance of its Co-Dx PCR Pro instrument and over-the-counter (OTC) COVID-19 test. The company plans to seek point-of-care (POC) clearance and additional tests in the future.
June 14, 2024 | 1:30 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Co-Diagnostics has submitted an FDA application for 510(k) clearance of its Co-Dx PCR Pro instrument and OTC COVID-19 test. This regulatory step is crucial for the company's market expansion and product offerings.
The submission for FDA 510(k) clearance is a significant regulatory milestone for Co-Diagnostics. If approved, it will allow the company to market its Co-Dx PCR Pro instrument and OTC COVID-19 test, potentially increasing revenue and market presence. The news is highly relevant and important for investors as it directly impacts the company's product offerings and regulatory status.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100