Home-use blood glucose monitoring system IVD

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Silverline Medical Pty Ltd

Class:

Class IIa

Manufactured by:

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

Therapeutic area:

62537 - Home-use blood glucose monitoring system IVD

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2021-12-23