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Home » Immunexpress’s SeptiCyte RAPID for Sepsis Diagnosis Gets FDA’s 510(k) Clearance
Immunexpress’s SeptiCyte RAPID for Sepsis Diagnosis Gets FDA’s 510(k) Clearance
Seattle, Wash.-based Immunexpress has been granted the FDA’s 510(k) marketing clearance for its SeptiCyte RAPID test to diagnose sepsis.
The rapid test, which was developed in partnership with Mechelen, Belgium-based Biocartis, runs on Biocartis’ Idylla molecular diagnostics platform.
The test has also earned CE-IVD mark certification.
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