The purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.
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