Device typeMultiple clinical chemistry analyte monitoring system IVD, point-of-care: A 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.
FDA categoryCALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, Glucose dehydrogenase, glucose, NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.), SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Device ID00093815712848
Catalog number71284
AvailabilityOver the counter
Single useYes
MRI safetyLabeling does not contain MRI Safety Information