QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...

Notably, Medicare pays only for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver. CMS on July 24 released Transmittal 10230 to inform ...

Following its milestone CLIA waiver clearance for its FebriDx® rapid point-of-care test and the completion of a placement, Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) will conduct an investor ...

Discusses CLIA Waiver Clearance for FebriDx, Capital Raise, and Commercialization Strategy March 30, 2026 6:00 ...

Cepheid 's CPHD rapid influenza and RSV assay - the Xpert Flu+RSV Xpress test - recently won the U.S. FDA 510(k) marketing approval and the Clinical Laboratory Improvement Achievements (CLIA) waiver.

Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured a major regulatory milestone in the US, with the Food and Drug Administration granting a CLIA waiver for its flagship FebriDx ...

The Food and Drug Administration (FDA) has granted the first CLIA waiver for Alere i Influenza A & B test, a nucleic acid-based test, for use in expanded healthcare settings. Prior to this clearance, ...

SUNNYVALE, Calif., Jan. 9, 2018 /PRNewswire/ -- Cepheid announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) ...

The US Food and Drug Administration (FDA) has cleared a complete blood cell count (CBC) test that can be run in more healthcare settings, including physicians' offices, clinics, or other types of ...