ST. PAUL, Minn., Jan. 21, 2026 /PRNewswire/ -- Zepto Life Technology has announced the launch of the FungiFlex (R) Mold Panel, a plasma-based molecular diagnostic test now available through its ...
Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals ...
CPT copyright 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The Food and Drug ...
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 ...
BOSTON, March 30, 2021 /PRNewswire/ -- binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) ...
This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the ...
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 ...
SAN DIEGO, CA - June 24, 2025 (NEWMEDIAWIRE) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it 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 ...
Gene Solutions, a global biotechnology company, and Pangea Laboratory, a CLIA-certified, CAP-accredited Next Generation ...
WEST LAFAYETTE, Ind., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Amplified Sciences, a clinical-stage life sciences diagnostic company that develops tests for early, more accurate detection of challenging ...
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