0aee2493-7e97-44c1-93e0-be37ff9e276bUpdatePublished22019-12-182019-10-29In Commercial Distribution00894030002000PrimaryGS1Embrace TALK Blood Glucose Monitor APX03AB0300824763358OMNIS HEALTH, LLC1Meter OnlyfalsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseMR ConditionalfalsefalseK09004300062537Glucose 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 CounterJJXSingle (Specified) Analyte Controls (Assayed And Unassayed)LFRGlucose Dehydrogenase, Glucosefalsefalse