Hemagen Diagnostics gets 510(k) for improved autoimmune tests:
This article was originally published in Clinica
Executive Summary
Hemagen Diagnostics has received US FDA clearance for two improved autoimmune ELISAs. The tests, which are used in rheumatic disease management, detect antibodies to extractable nuclear antigens including Sci-70, Jo-1, Sm/RNP, Sm, SS-A and SS-B.