Intended Use - NOVA BIOMEDICAL MAX PRO CREATININE eGFR Instructions For Use Manual

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The Nova Max Pro Creatinine and eGFR Meter System is intended

for in vitro diagnostic use for the quantitative measurement of

creatinine in capillary whole blood obtained from the fingertip

for screening of kidney health by calculating Estimated Glo-

merular Filtration Rate (eGFR). It is intended for multiple patient

use in Near-Patient/Point of Care and professional healthcare

settings. The system should only be used with the Nova Max Pro

Creat eGFR Creatinine Test Strips and Nova Max Pro Creat eGFR

Creatinine Control Solutions and with single-use, auto-disabling

lancing devices. It is not intended to diagnose a specific kidney

disease or condition. The system should not be used to alter

kidney disease treatment by changing any medication schedule

or dosage unless specifically instructed by a healthcare profes-

sional.

eGFR MeterIFU Manual PRO PN64322.indd 1

Intended Use

1/14/22 3:42 PM

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