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 ...
FDA clearance, panel choice, accuracy, on-site speed and supplier reliability for compliant workplace programs.
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
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 ...
The Centers for Medicare & Medicaid Services has rescinded a pandemic-era memo that allowed expanded use of point-of-care antigen COVID-19 tests under Clinical Laboratory Improvement Amendments (CLIA) ...
CPT copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The Food and Drug ...
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 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 ...
Following its milestone CLIA waiver clearance for its FebriDx® rapid point-of-care test and the completion of a placement, Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) will conduct an investor ...
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