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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, ...
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 ...
Diagnostics Direct, LLC., a leading provider of in-office diagnostic tests, is pleased to announce the launch of the first CLIA-Waived rapid treponemal syphilis test: Syphilis Health Check™. The U.S.
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) ...
A recent press release by Abbott announced their latest rapid influenza diagnostic test (RIDT), BinaxNOW® Influenza A & B Card 2. Abbott (NYSE: ABT) today announced the availability1 of its latest ...
Theranos just received an FDA clearance that’ll allow its newly approved herpes diagnostic to be used outside traditional clinical laboratories. This CLIA Waiver is a sign that the storied ...
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 ...
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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