Böserjunge & Zocker Forum: Community User: Böserjunge
..the T2Dx Instrument, T2Bacteria Panel, and T2Candida Panel are already FDA 510(k) cleared. These are the only FDA-cleared products able to detect sepsis-causing pathogens directly-from-blood (i.e., blood culture-independent). Three products in our pipeline have received FDA Breakthrough Device designation: T2Resistance Panel, T2Lyme Panel, and Candida auris test. As we have communicated, we are also awaiting FDA 510(k) clearance for T2Biothreat Panel.
..the T2Dx Instrument, T2Bacteria Panel, and T2Candida Panel are already FDA 510(k) cleared. These are the only FDA-cleared products able to detect sepsis-causing pathogens directly-from-blood (i.e., blood culture-independent). Three products in our pipeline have received FDA Breakthrough Device designation: T2Resistance Panel, T2Lyme Panel, and Candida auris test. As we have communicated, we are also awaiting FDA 510(k) clearance for T2Biothreat Panel.
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