Sept. 12, 2007

BD Diagnostics, Franklin Lakes, NJ, has made a 510(k) submission to the FDA for additional claims for the BD GeneOhm StaphSR assay. This will be the first assay for rapid and simultaneous identification of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus colonized in the nasal passage.

The assay is a simple test that provides results within 2 hours directly from nasal swabs. It is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take 2 days to generate results.