CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
January 2018—Instrumentation Laboratory announced FDA 510(k) clearance of the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls. The assay is an on-demand, fully automated chemiluminescent reagent for use on hemostasis testing systems for the qualitative detection of platelet factor 4 (PF4)-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia. It provides enhanced detection of HIT antibodies on ACL AcuStar Hemostasis Testing Systems in specialty and hospital hemostasis laboratories. HemosIL HIT-IgG(PF4-H) is liquid, ready to use, and delivers results in minutes.
Instrumentation Laboratory, 800-955-9525