Business Insider

binx health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test, Expanding Critical Access to Single-Visit Diagnoses

BOSTON, March 30, 2021 /PRNewswire/ -- binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) ...
Nasdaq

QuidelOrtho's (QDEL) Rapid Antigen Test Gets CLIA Waiver

QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
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 ...
Business Wire

Amid National Surge in Sexually Transmitted Infections binx health Announces Launch of Reagent Rental Program for Decentralized, Rapid, Point-of-Care Testing Platform for ...

BOSTON--(BUSINESS WIRE)--binx health, a healthcare technology and women’s health company focused on making routine testing broadly accessible and convenient, announced today the launch of its ...
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 ...
RAPS

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
Hosted on MSN

Lumos starts paediatric CLIA waiver study for point-of-care respiratory test

Lumos starts FebriDx CLIA-waiver study in US for patients 2-12 years of age 500-800 patients expected to be enrolled at 20 sites over next 12 months Successful outcome will broaden market in US for ...
Business Insider

binx health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test, Expanding Critical Access to Single-Visit Diagnoses

First ever 30-minute, CLIA-waived, molecular PCR Test for CT/NG now available for OBGYN, physician offices and retail settings holding certificates of waiver BOSTON, March 31, 2021 /PRNewswire/ -- ...