Diagnostics

InfinixBio designs and conducts studies to support both 510(k) and Laboratory Developed Tests (LDT) submissions for medical devices and diagnostic tests. We work collaboratively to design the proof of concept for the diagnostic assay, develop and test the assay, enabling a 510(k) submission. Our process often involves working with many different providers ranging from CRO’s, engineers, clinical labs, to device manufacturers.

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