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EVALUATION OF THE PERFORMANCE OF THE TRUEBALANCE™ BLOOD GLUCOSE MONITORING SYSTEM USING THE ISO 15197:2003 ACCURACY AND USER EVALUATION REQUIREMENTS Douglas E. Bell, PhD
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Document Date: 2014-10-23 13:08:58


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City

Geneva / Lauderdale / /

Company

Nipro Diagnostics Inc. / Clinical Services Nipro Diagnostics Inc. / Vitro Diagnostic Test Systems / /

Facility

Laboratory Reference Result / /

IndustryTerm

in vitro glucose monitoring systems / healthcare professionals / healthcare professional results / study protocol / trained healthcare professionals / trained healthcare professional / Diabetes Care / healthcare / healthcare professional / /

MedicalCondition

diabetes / gestational diabetes / Diabetes Mellitus / MS / /

Organization

International Organization for Standardization / International Standardization Organization / FDA / International Organization for Standardization Parkes / /

Person

Douglas E. Bell / Teri A. Sasse / /

Position

study investigator / Director / Senior Director Product Development / /

Product

B300 / /

ProgrammingLanguage

FL / /

ProvinceOrState

Florida / /

Technology

ISO protocol / The study protocol / /

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