LEXINGTON, Mass.--(BUSINESS WIRE)--T2 Biosystems today announced that it has filed a 510(k) premarket submission for T2Dx and T2Candida with the U.S. Food and Drug Administration (FDA).”
The premarket submission includes clinical trial and other data providing evidence that the T2Dx instrument and the T2Candida test panel may identify specific life-threatening sepsis-causing pathogens directly from an unpurified blood sample as fast as three hours, rather than the two to five days typically required for blood culture-based diagnostics.
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