9. CLSI POCT12-A3 Point of Care blood glucose
testing in acute and chronic care facilities;
Approved Guideline – Third Edition,
January 2013.
10. International Organization for Standardization.
In vitro diagnostic test systems. Requirements
for blood-glucose monitoring system for self
testing in managing diabetes mellitus.
Reference number ISO 15197:2013 (E).
Geneva: International Organization for
Standardization; 2013.
11. Good Laboratory Practices for Waived Testing
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2008: www.cdc.gov/mmwr/preview/mmwrhtml/
rr5413a1.htm.
TRUE METRIX
®
PRO System Comprehensive Resource Guide (GDH-FAD Enzyme)
References 43
References
1. FDA Public Health Notification: Use of Fingerstick
Devices on More than One Person Poses Risk
for Transmitting Blood Borne Pathogens: Initial
Communication Update 11/29/2010
[Electronic
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AlertsandNotices/ucm224025.htm.
2. CDC Clinical Reminder: Use of Fingerstick
Devices on More Than One Person Poses Risk for
Transmitting Bloodborne Pathogens
[Electronic
Version]. Retrieved February 22, 2012 from
http://www.cdc.gov/injectionsafety/Fingerstick-
DevicesBGM.html.
3. International Organization for Standardization.
In vitro diagnostic test systems. Requirements
for blood-glucose monitoring system for self-
testing in managing diabetes mellitus. Reference
number ISO 15197:2003 (E). Geneva: International
Organization for Standardization; 2003.
4. Data on file.
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Blood Glucose Meters, Getting the Most
Out of Your Meter.
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Summary of Contents for True Metrix Pro
Page 3: ...Introduction...
Page 9: ...System Components...
Page 16: ...Clinical Information...
Page 21: ...Meter Setup Quality Control Testing...
Page 29: ...Blood Glucose Testing...
Page 32: ...Diabetes Data Management Capabilities...
Page 37: ...System Maintenance...
Page 43: ...Training Program...
Page 53: ...References...
Page 55: ...Appendix A Clinical Studies Note Available for download at www niprodiagnostics com...
Page 57: ...Appendix C Safety Data Sheets...
Page 60: ...Appendix D Forms...