cee94b26-2592-438e-8d45-13126932dc12NewPublished12021-05-202021-05-12In Commercial DistributionMHC18490502PrimaryHIBCCMHC18490500Unit of UseHIBCCBluLink849050169895245MHC MEDICAL PRODUCTS, LLC50BluLink Test Strips 50ctfalsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationfalsetrueK20139600062537Glucose 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.falseActiveCGAGlucose Oxidase, Glucosefalsefalse