WNCT

CytoChip Receives FDA Clearance and First CLIA Waiver for a Cartridge-Based Complete Blood Count Test

The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...
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, ...
Seeking Alpha

Nuclein Receives Dual FDA 510(k) Clearance and CLIA Waiver for DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System

AUSTIN, Texas, Jan. 6, 2025 /PRNewswire/ -- Nuclein, a leader in rapid, point-of-care molecular diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance ...
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, ...
WOOD-TV

Visby Medical™ Submits Men's Sexual Health Test to FDA for Clearance and CLIA Waiver

If cleared, Visby Medical's test will provide fast PCR results for Chlamydia and Gonorrhea using male urine samples in diverse clinical settings, meeting clinical demand and established medical ...
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 ...