d79cbfaa-25b5-422d-8b17-c71a622453d1UpdatePublished42019-10-032016-05-01In Commercial Distribution00891237001478PrimaryGS110891237001475PackageGS1008912370014785In Commercial DistributionInner Case20891237001472PackageGS11089123700147510In Commercial DistributionOuter CaseEasy Talk Blood Glucose Monitoring System62771478783518983HOME AIDE DIAGNOSTICS, INC.1Blood Glucose Testing Monitor to be used with Easy Talk or Easy Plus II test strips Test: Glucose Sample: Whole Blood Principle of the test method: Amperometric, glucose oxidase Test sites: Fingertip, forearm Measurement time: 6 seconds Code required: No code device Measurement Range: 20~600 mg/dL (1.1~33.3mmol/L ). Batteries: 2 x AAA 1.5 V Alkaline 24A LR03falsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue18009150116info@homeaide.us62537Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.falseActiveNBWSystem, Test, Blood Glucose, Over The Counterfalsefalse