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 ...
On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”). FDA, Guidance for Industry and FDA Staff, ...
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 ...
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 ...
SAN DIEGO — TearLab Corporation did not gain approval from the U.S. Food and Drug Administration for its Clinical Laboratory Improvement Amendments certificate application, the company announced in a ...
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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