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PHASE Scientific Announces U.S. FDA CLIA Waiver for FebriDx®

PHASE Scientific Announces U.S. FDA CLIA Waiver for FebriDx®

PHASE Scientific, the exclusive U.S. distributor of FebriDx® under its previously announced distribution agreement with Lumos Diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for FebriDx®, following the test’s 510(k) clearance (K260787).
 

The CLIA waiver materially expands the settings in which FebriDx can be used, enabling broad adoption across CLIA-waived point-of-care (POC) environments and significantly increasing the reachable customer base. FebriDx is a rapid POC test that helps clinicians differentiate between bacterial and non-bacterial respiratory infections in approximately 10 minutes using a fingerstick blood sample. Read More >

Phase Scientific

Phase Scientific News & Announcements

PHASE Scientific is a diagnostics company dedicated to expanding access to reliable, high-quality testing solutions. Founded by bioengineers from a leading research university in Los Angeles, California, we have built a reputation as a trusted partner to healthcare providers, retailers, and patients.

Our portfolio spans infectious disease, oncology, and preventive health, with a mission to empower people with actionable insights for better health decisions. By combining scientific innovation with agility and customer focus, we deliver products that meet rigorous regulatory standards while addressing real-world needs in clinical, point-of-care, and at-home settings.

PHASE Scientific Americas partners across the healthcare ecosystem to expand access, improve outcomes, and put people at the center of diagnostics.

RXinsider Staff

Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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