Metrix BioMed Inc. announced today the opening of Metrix Labs, a toxicology laboratory service to meet the needs of physicians who are utilizing CLIA waived testing for drugs of abuse screening and ...
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 ...
FDA clears Sekisui Diagnostics’ rapid combo test for COVID-19 and flu A&B, offering CLIA-waived, 510(k)-cleared pathogen ...
SALT LAKE CITY, June 16, 2026 /PRNewswire/ -- Clinical laboratories, including ARUP Laboratories, are reviewing newly introduced federal legislation to modernize oversight of laboratory-developed ...
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 ...
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 ...
CytoChip showcases CitoCBC®â€”the first cartridge-based Complete Blood Count (CBC) analyzer with both FDA 510(k) clearance and CLIA Waiver—and announces CitoPRP, a new cartridge-based system for ...
Understanding CLIA certification and how it differs from CAP accreditation and ISO 15189 is essential before a sequencing laboratory moves from research into clinical testing, because these frameworks ...
Dublin, July 05, 2023 (GLOBE NEWSWIRE) -- The "Point-of-Care Glucose Testing Market Size, Share & Trends Analysis Report By Product (Accu Check Aviva Meter, Onetouch Verio Flex, i-STAT), By Region, ...
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In 2019, the first cases of SARS-CoV-2 were detected in Wuhan, China, and by early 2020 the first cases were identified in the United States. SARS-CoV-2 infections increased in the US causing many ...
LINCOLN, Neb--(BUSINESS WIRE)--Celerion, a leading clinical research organization, proudly announces its recent achievement of obtaining the Clinical Laboratory Improvement Amendments (CLIA) ...