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 ...

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.

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 ...

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 ...

Exclusive US distributor Phase Scientific will now roll out the rapid test via an established commercial footprint and other distribution agreements.

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 ...

The Small Cap Wrap: GreenTech wraps up first drill program at Munni Munni; Imugene launches $20M capital raise to advance azer-cel; Titan Minerals strengthens Dynasty scale and more ...

HAUPPAUGE, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission to the U ...

In the CLIA study, FebriDx showed it was accurate and reliable for trained professionals and untrained users alike. The diagnostic tool delivered accurate results 99.1% of the time for bacterial ...

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 ...

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, ...