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 CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...
Nuclein’s DASH SARS-CoV-2 & Flu A/B Test, which is designed for use with the DASH Rapid PCR System, has gained the US Food and Drug Administration (FDA) 510(k) clearance, as well as a Clinical ...
STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that ...
The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...
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 ...
First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, ...
Devyser has inaugurated its CLIA-certified laboratory and performed the first patient fetal RhD test
STOCKHOLM, June 30, 2023 /PRNewswire/ -- Devyser has inaugurated its CLIA-certified laboratory in Atlanta, Georgia. The laboratory will offer clinical test services for hereditary diseases, oncology, ...
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