Home » MicroPhage Gets CE Marking for Rapid Staph Test
MicroPhage Gets CE Marking for Rapid Staph Test
MicroPhage received marketing authorization in Europe
for its instrument-free, rapid test that can identify Staphylococcus aureus and determine methicillin resistance or susceptibility in five hours. The company
plans to file a 510(k) application for the product soon with the FDA, it says in a statement Monday. It is comparing the test to “gold standard” lab
tests, which can take up to three days to deliver results, in a clinical study at four medical centers in the U.S.
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