Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Cue Health Gets FDA EUA for Monkeypox Molecular Test
The nucleic acid amplification test returns results in 25 minutes and is authorized for use in professional point-of-care settings.
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.
Oxford Gene Technology Obtains CE-IVDR Certificates for FISH Products
According to the Oxford, UK-based company, the probes are important for patient management while treating hematological cancers and prenatal conditions.