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Accuracy & Reproducibility

Quality Policy

Cholestech's Quality Management System is certified to ISO 13485:2003 - the most stringent, comprehensive and detailed certification for medical device companies.

Learn more about our commitment to quality

Cholestech LDX® System

CRMLN Certified

The Cholestech LDX System has been certified by the Cholesterol Reference Method Laboratory Network (CRMLN). This certification validates that the system meets the gold standards for accuracy and reproducibility developed by the Centers for Disease Control and Prevention (CDC) for the measurement of total and HDL cholesterol, consistent with the National Cholesterol Education Program (NCEP) analytic goals. Unlike with noncertified systems, health care professionals can be confident that the Cholestech LDX delivers quality lab accurate results that our customers can trust.



Cholestech GDX™ System

NGSP Certified

The Cholestech GDX System has received National Glycohemoglobin Standardization Program (NGSP) certification every year since its introduction. NGSP certification verifies that the results generated by the Cholestech GDX are traceable to those reported in the Diabetes Control and Complications Trial (DCCT), which is used as a benchmark for performance by commercial clinical laboratories. The GDX System delivers the quality, convenience, speed and accuracy you've come to expect from Cholestech.