59ab430c-514c-4622-a996-83b0d92e27efUpdatePublished82023-10-182016-08-12In Commercial Distribution30093815998373PackageGS1000938159983724In Commercial DistributionCase00093815998372PrimaryGS157599-9837-1SecondaryNDC/NHRICPrecision Xtra9983799837966390890ABBOTT DIABETES CARE INC1Precision Xtra Blood Glucose & Ketone Monitoring SystemfalsefalsefalsetruefalsefalsetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue+1(800)527-3339xx@xx.xxK04081400062643Multiple clinical chemistry analyte monitoring system IVD, home-useA collection of devices including a portable, electrically-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 together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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.falseActive62644Multiple clinical chemistry analyte monitoring system IVD, point-of-careA collection of devices that includes one or more portable, electrically-powered instruments (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together exclusively at the point-of-care by medical professionals for the quantitative measurement of more than one clinical chemistry analyte [e.g., glucose, ketones, lipid(s), and/or creatinine] in a whole blood specimen. Some types may also include measurement of haemoglobin and/or haematocrit for rapid diagnosis of anaemia and/or blood loss.falseActiveNBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTERLFRGlucose dehydrogenase, glucoseJINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)Storage Environment Temperaturefalsefalse