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 ...
To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...
With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable ...
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 ...
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) ...
Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy INDIANAPOLIS, Oct. 1, 2012 ...
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 ...
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Nursing homes will be required to have Clinical Laboratory Improvement Amendments (CLIA) waivers to perform COVID-19 point-of-care tests. As a result, the Centers for Medicare & Medicaid Services is ...
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 ...
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 ...
CLIA stands for Clinical Laboratory Improvement Amendments. The CLIA of 1988 established certification requirements and more stringent quality standards for laboratory testing of human specimens.
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