Shield Diagnostics (UK) gets 510(k) for anti neutrophil cytoplasmic antibodies (ANCA):
This article was originally published in Clinica
Executive Summary
Shield Diagnostics (UK) has received US FDA clearance to market two anti-neutrophil cytoplasmic antibodies. The autoimmune disease assays - anti-PR3 (c-ANCA) and anti-MPO (p-ANCA) - are both part of Shield's Diastat range, which now has 17 FDA-approved tests.