June 2017—LGC Maine Standards’ Validate Heparin calibration verification/linearity test kit received FDA 510(k) clearance for use on Instrumentation Laboratory’s ACL TOP 500 hemostasis test systems. The Validate Heparin kit evaluates heparin anti-Xa activity in a human plasma matrix, is prepared using CLSI’s EP06-A recommended equal delta method for linearity testing, and is liquid, ready to use.
LGC Maine Standards, 207-892-1300