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 ...
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 ...
CPT copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The Food and Drug ...
The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...
BOSTON, March 30, 2021 /PRNewswire/ -- binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) ...
The Centers for Medicare & Medicaid Services has rescinded a pandemic-era memo that allowed expanded use of point-of-care antigen COVID-19 tests under Clinical Laboratory Improvement Amendments (CLIA) ...
Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured a major regulatory milestone in the US, with the Food and ...
BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a ...
Following its milestone CLIA waiver clearance for its FebriDx® rapid point-of-care test and the completion of a placement, ...
Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent ...
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