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 ...

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, ...

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 ...

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 ...

Lumos enrols 61 of required 120 bacterial positive patients in US CLIA waiver clinical study for FebriDx Study to be completed by Q4 2025 with US FDA CLIA waiver application to be submitted in October ...

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 ...