Search Results

The Nova Max Creat eGFR Monitoring System is comprised of the Nova Max Creat eGFR Monitor and the Nova Max Creat eGFR Test Strips.

The Nova Max Creat eGFR Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of creatinine and estimation of glomerular filtration rate (eGFR) in fresh capillary whole blood obtained from the fingertip of adult patients aged 18 and above. The system is intended for single patient home use by prescription only and should not be shared. It is intended for use by patients as an aid to monitor kidney function on the order of a treating healthcare professional.

The Nova Max Creat eGFR Monitoring System consists of Nova Max Create eGFR Monitor and Nova Max Create eGFR Creatinine-Test Strips. The Nova Max Creat eGFR test strips, Nova Max Creat eGFR control solution (Level 1 and Level 2), and a single-use, disposable, 21 gauge safety lancet can be purchased separately.

Nova Max Creat eGFR Monitor
The monitor is intended to be used in conjunction with the Nova Max Creat eGFR Creatinine-Test Strips to measure creatinine and calculate estimated glomerular filtration rate (eGFR) using capillary whole blood obtained from the fingertip. The hand-held monitor is lightweight, portable, utilizes a 2.8" color touchscreen display and has capability for storage (400 test samples and/or quality control samples) and review of data. The monitor is powered by a rechargeable, 3.7 V Li polymer battery.

Nova Max Creat eGFR Creatinine-Test Strips
The Nova Max Creat eGFR Creatinine-Test Strip is designed with an electrode that measures creatinine levels. Creatinine in the capillary whole blood sample mixes with the reagents in the test strip to produce an electric current. The amount of current that is produced depends on how much creatinine is in the sample. A digital readout is displayed on the monitor in 30 seconds, the eGFR is calculated using patient information and the measured creatinine level. The test strips are for single use only.

Nova Max Creat eGFR Creatinine Control Solutions
The Nova Max Creat eGFR Creatinine Control Solution is used as a quality control check to ensure that the Nova Max Creat eGFR Monitor and the Nova Max Creat eGFR Creatinine-Test Strips are working properly as a system. There are two levels of Nova Max Creat eGFR Creatinine Control Solution. Each level of control solution has a known creatinine concentration that reacts with the reagents in the test strip.

N/A

Ask a specific question about this device