Under CLIA, waived tests must be simple with low probability of erroneous results. The CLIA-waived lipid profile tests that fall under the Piccolo Blood Chemistry Analyzer line are available in a ...
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 ...
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 ...
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 ...
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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.
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