CLIA
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.
Thermo Fisher Scientific to Promote Devyser Laboratory Services for Pharma Research
The companies will work together to market Devyser Diagnostics' CLIA-certified lab services to pharmaceutical companies for research and development projects.
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.
BioMérieux Gets CLIA Waiver for BioFire SpotFire Respiratory Panel Mini
The CLIA waiver now allows the SpotFire system and two existing panels to be used by non-lab professionals at the point of care, the firm said.
Devyser Gets CLIA Certification for Atlanta Lab
The Sweden-based firm said it will use the laboratory to perform testing for hereditary diseases, oncology, post-transplant monitoring, and other patient management.