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.
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.
A. Menarini to Distribute Credo Diagnostics Coronavirus Assay Kit, Respiratory Infection Assays
Credo Diagnostics recently received the CE mark for the coronavirus test, which can provide results in 20 minutes.
Mar 21, 2019
GenePOC Strep A Test Granted FDA Clearance
Mar 14, 2019
Oct 25, 2018
Abbott Molecular Flu, Strep Tests Get FDA Clearance
Oct 5, 2017
Cepheid Xpress Strep A Test Clears FDA
Oct 25, 2016
FDA Clears Quidel Rapid MDx Strep Test
Jul 12, 2016
Oct 20, 2015