510(k): Existence of a predicate device (Veridex) will reduce time and risk for
This is a monitoring test, not a primary diagnostic
Patents: USA (Number 7,695,966 Avril 2010) et PCT WO/2008/155398).
Technology based on Immunochemistry including microfluidic chips, that are
based on immuno-chemistry may lower the rate of detection, can be time
consuming and are very expensive to run.
Existing reimbursement in USA: CPT Codes (88346, 88361, 88313) soon in EU
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