Abbott FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

から入手可能:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

クラス:

Class C IVD

製:

Abbott Diabetes Care Limited

治療領域:

General Hospital

適応症:

The FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (D-glucose) in fresh capillary whole blood (fingertip), and of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood samples. The FreeStyle Precision Pro system is for professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs. Healthcare professionals may also use the product for the quantitative measurement of glucose in venous, arterial or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

製品概要:

Device System Info:[Device with measuring function], Quantitative measurement of glucose (D-glucose) in fresh capillary whole blood (fingertip), and of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood samples.; Models: FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System - 71337-70, FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System (Replacement Meter Kit) - 71335-70, FreeStyle Precision Pro Glucose Test Strips (100 CT) - 71283-70, FreeStyle Precision Pro β-Ketone Test Strips (50 CT) - 71287-70, FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System Wireless Set Up Utility - 71205-70, FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System MeterCom - 71349-70, KIT, QCM 3.0 W/SP4 ENG - 99897-04, Upload Cable - 98754-01, DOCKING STATION - 70653-02, Medisense Glucose and Ketone Control Solution - 99895-05

承認日:

2013-12-26