FDA clears Hycor's vasculitis test:
This article was originally published in Clinica
Executive Summary
Hycor Biomedical has received US FDA 510(k) clearance to market its Anti-MPO (p-ANCA) ELISA autoimmune test. The p-ANCA test is a complement to Hycor's FDA-cleared Anti-Pr-3 (c-ANCA). The two tests are used to differentiate between various forms of vasculitis, an inflammation of the blood vessels. They can be performed manually and in a fully automated mode on Hycor's new HYTEC 288 Plus automated immunoassay system, said the Garden Grove, California company.