Nasdaq

Axim Biotechnologies Files Pre-Submission With FDA for CLIA Waiver Pathway on Lactoferrin Point-of-Care Diagnostic Test

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 Financial

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

The FINANCIAL — Roche on September 22 announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test ...
abc27

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Visby Medical ™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration (FDA) for ...
Morningstar

Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test

First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, ...
technologynetworks

Roche Receives FDA Clearance With CLIA Waiver for Its First Molecular Point-of-Care Test

Roche announced that its first point-of-care test for the detection of Bordetella infections, including whooping cough (pertussis), has been granted U.S. Food and Drug Administration (FDA) 510(k) ...
East Oregonian

Visby Medical™ Receives FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your hand, ...