JD Supra

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...
Business Wire

Celerion Achieves Milestone With CLIA Certification for Its Bioanalytical Laboratory, Expanding Capabilities in Clinical Trials and Diagnostic Testing

LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...
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

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

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 ...