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 ...
The role of community pharmacies in health care has evolved and expanded in recent years. Many community pharmacies now offer health and wellness services related to identifying, preventing, and ...
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Henry Schein Enters Exclusive Distribution Agreement for CytoChip’s CLIA-Waived Hematology Analyzer
Henry Schein, Inc. (Nasdaq: HSIC) has entered into a new exclusive distribution agreement with CytoChip Inc. for its flagship product, the CitoCBC® system, a U.S. Food and Drug Administration (FDA) ...
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 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 ...
MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a ...
SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Visby Medical ™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for ...
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