Group A streptococcus
BioMérieux Respiratory/Sore Throat Mini Panel Gets FDA Special 510(k) Clearance, CLIA Waiver
The firm said that it expects its SpotFire Respiratory/Sore Throat (R/ST) Panel Mini test to be available in the US in the third quarter of 2024.
The Boston-based company has developed a loop-mediated amplification assay and a novel lateral flow strip technology.
Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
The firm sells a rapid, point-of-care, PCR platform for infectious disease diagnostics, including SARS-CoV-2, influenza, respiratory syncytial virus, and strep A.
Roche Diagnostics, Beckman Coulter, BioMérieux, Mesa Biotech Receive FDA 510(k) Clearances in November
The BioFire Defense subsidiary of BioMérieux obtained clearance for its FilmArray Global Fever Panel External Control Kit, used with the FilmArray Global Fever Panel.
Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.