CLIA
Top Five Articles on 360Dx Last Week: Dx Companies' Plans for POC Testing; IVDR Rollout; More
Last week, readers were most interested in a story about the hurdles faced by companies bringing routine testing at the point of care.
QuidelOrtho Nabs CLIA Waiver for COVID-19 Antigen Test
The test runs on the company's Sofia 2 fluorescent immunoassay analyzer, both of which received de novo authorization from the FDA earlier this year.
BioMérieux Submits Dual FDA Marketing, CLIA Waiver Application for Respiratory, Sore Throat Panel
The French diagnostics maker is seeking both 510(k) clearance and a CLIA waiver for the multiplex PCR test, which can be used at the point of care.
The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk.
Top Five Articles on 360Dx Last Week: Siemens Healthineers Layoffs and Atellica Focus; and More
Last week, readers were most interested in a story about changes at Siemens Healthineers as it plans to shut down some of its legacy instruments.
May 8, 2023
Devyser Gets CLIA Certification for Atlanta Lab
Mar 29, 2023
Oct 11, 2022
Aug 19, 2022
Jun 6, 2022
Bluestar Genomics Gets CLIA Certification
Feb 9, 2022
Mar 30, 2021
Binx Health Chlamydia and Gonorrhea Test CLIA Waived
Dec 10, 2020