CLIA stands for Clinical Laboratory Improvement Amendments. The CLIA of 1988 established certification requirements and more stringent quality standards for laboratory testing of human specimens.
BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a ...
DUBLIN--(BUSINESS WIRE)--The "CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA" conference has been added to ResearchAndMarkets.com's offering. CLIA Waiver applications declined ...
SANTA ANA, Calif., Sept. 15, 2025 /PRNewswire/ -- Today, Autonomous Medical Devices Incorporated (AMDI) announced its submission to the US Food and Drug Administration (FDA) of a dual 510(k) and CLIA ...
Nursing homes will be required to have Clinical Laboratory Improvement Amendments (CLIA) waivers to perform COVID-19 point-of-care tests. As a result, the Centers for Medicare & Medicaid Services is ...
The New BVA System is Designed to be Significantly Faster, Simpler and Give Results at the Bedside Oak Ridge, TN, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader ...
With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable ...
Lumos submits for FDA CLIA waiver approval for FebriDx, a diagnostic test for bacterial and non-bacterial infections. In the CLIA study, FebriDx showed it was accurate and reliable for trained ...
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 ...
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