The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to the marketed product.
Sponsor:
Ascensia Diabetes Care
Information provided by (Responsible Party):
Ascensia Diabetes Care
Corporate Headquarters and Labs
70 New Dutch Ln
Fairfield, NJ 07004
973-576-5957
Satellite Clinical Lab Location
304 Wootton St.
Boonton, NJ 07005
FDA
Registration# 1000151293
CPT℠ is registered with FDA (FEI # 1000151293) as a Drug Establishment (GMP/GLP/GCP) and a Cosmetic Facility.
DEA
Registration# RC0199744 (Analytical Lab)
Schedule I-V license
Remember, Schedules I-II require DEA Form 222
Registration# RC0171568 (Researcher)
US EPA/NJ DEP
Registration# NJD982726648