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 ...
On Sept. 2, 2026, the New York State Department of Health amended regulations that affect clinical laboratories holding New York Clinical ...
The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part ...
The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
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PALO ALTO, Calif.--(BUSINESS WIRE)--Theranos, Inc. (Theranos) today announced that its test and Theranos test system for the herpes simplex 1 virus IgG (HSV-1), which was cleared by the U.S. Food and ...
The FDA requires that biomarker testing to select patients for registration trials must be performed in a CLIA-certified laboratory environment CLIA certification for the Allarity Therapeutics Medical ...
Lumos Diagnostics secures FDA CLIA waiver for FebriDx, unlocking US$1B market opportunity Proactive uses images sourced from Shutterstock Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has ...
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 ...
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