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 ...

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 ...

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 ...

The Centers for Medicare & Medicaid Services has rescinded a pandemic-era memo that allowed expanded use of point-of-care antigen COVID-19 tests under Clinical Laboratory Improvement Amendments (CLIA) ...

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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 ...

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) ...

LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...

First ever 30-minute, CLIA-waived, molecular PCR Test for CT/NG now available for OBGYN, physician offices and retail settings holding certificates of waiver BOSTON, March 31, 2021 /PRNewswire/ -- ...