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) ...
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, ...
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 ...
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.
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 ...
The Alere i Influenza A & B test--Courtesy of Alere Alere ($ALR) won an FDA CLIA waiver for its molecular influenza test, giving the company a boost amid ...
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