Home-use blood glucose monitoring system IVD

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Dostępny od:

Silverline Medical Pty Ltd

Klasa:

Class IIa

Wyprodukowano przez:

Tyson Bioresearch Inc 5F No 16 18 20 22 Kedong 3rd Road, Zhunan Township, Miaoli County, 35053 Taiwan

Dziedzina terapeutyczna:

62537 - Home-use blood glucose monitoring system IVD

Wskazania:

A collection of devices including a portable, battery powered glucometer, lancets and a lancing device, intended to be used together with blood glucose test strips for the quantitative measurement of blood glucose in fresh capillary whole blood. The system is intended for home use by persons with diabetes, or in a clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. The system is not intended for neonatal testing, nor is it intended for the diagnosis of or screening for diabetes mellitus.

Status autoryzacji:

A

Data autoryzacji:

2021-12-23