Clinical Laboratory Improvement Amendments, or CLIA, are a high bar as set by the US Government under Clinical Laboratory Improvement Amendment 42 CFR 493.1253 to obtain and maintain quality ...
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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 ...
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 ...
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 ...
Palo Alto lab enables faster turnaround times and increased capacity for ultrasensitive, amplicon-based liquid biopsy testing for US customers PALO ALTO, Calif.--(BUSINESS WIRE)--Molecular diagnostics ...
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 ...
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