DiaSorin Gets FDA 510(k) for Molecular COVID-19/Flu Assay
The real-time RT-PCR Simplexa COVID-19 & Flu A/B Direct assay is designed for use on the company's Liaison MDX instrument, with results in about one hour.
Becton Dickinson Gets FDA 510(k) Clearance for High-Throughput Vaginitis Test
The BD Vaginal Panel, which tests for the three most common vaginitis pathogens, is the third assay for the high-throughput, fully automated BD Cor system.
Visby Medical Point-of-Care STI Test Gets FDA 510(k) Clearance, CLIA Waiver
The PCR test detects sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women.
Biocartis Nabs FDA 510(k) Clearance for Lynch Syndrome Screening Assay
The Idylla MSI Test identifies microsatellite instability in colorectal cancer tumors to aid in the identification of potential Lynch syndrome.
DiaSorin Gets FDA 510(k) Clearance for Molecular CMV Test
The test, which runs on the company's Liaison MDx system, is designed for use with both saliva swab and urine specimens from newborns 21 days old or younger.