FiercePharma

FDA grants CLIA-waived status to CoaguChek XS Plus system for PT/INR testing at the point of care

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy INDIANAPOLIS, Oct. 1, 2012 ...
Mena FN

Cytochip Receives FDA Clearance And First CLIA Waiver For A Cartridge-Based Complete Blood Count Test

(MENAFN- EIN Presswire) The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. IRVINE, CA, UNITED ...
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 ...
Nasdaq

Chembio Announces the Receipt of CLIA Waiver for its DPP HIV-Syphilis System

MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a ...
Mena FN

Roche Receives FDA Clearance With CLIA Waiver For Cobas® Liat Molecular Tests To Diagnose Sexually Transmitted Infections At The Point Of Care

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic. 1 FDA CLIA-waived tests broaden access to ...