Solutions

CardioChek PA

Download

• CardioChek User Manual
• CardioChek Quick Reference Guide

White Papers

• CardioChek Accuracy Study

Specifications

• Easy to use
• Battery operated
• Results within 2 minutes
• No refrigeration of test strips
• Internal result storage/review
• Printer / PC compatible
• CLIA-waived
• Single and combination testing capability

ISO9001 Certified -- ISO 13485: 2003

• Certification specific to Medical Device and Pharmaceuticals
• CMDCAS specific for sale in Canada
• Received August 2003
• Successful annual audit completion = October 2007

IVDD

• CE Mark / CE Labeling

CRMLN CERTIFICATION

• Cholesterol Reference Method Laboratory Network
• Established by the CDC
• Provides evidence of traceability to the National Reference
• System for Cholesterol (NRS/CHOL)

FDA COMPLIANT

January 2004 Audit = Two 483’s