www.fdanews.com/articles/192938-luminex-grabs-fda-clearance-for-mrsa-nasal-swab-assay
Luminex Grabs FDA Clearance for MRSA Nasal Swab Assay
October 2, 2019
The FDA granted Luminex 510(k) clearance for its Aries MRSA assay, an in vitro diagnostic test that uses nasal swabs to directly detect methicillin-resistant Staphylococcus aureus (MRSA).
The diagnostic is run on Luminex’s Aries system, that features six FDA cleared and seven CE marked assays and can also run lab-developed tests.
MRSA is usually spread by direct contact with an infected wound or contaminated hands, often those of healthcare providers, according to the CDC.