Home-use blood glucose monitoring system IVD

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Pieejams no:

Silverline Medical Pty Ltd

Klase:

Class IIa

Ražojis:

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

Ārstniecības joma:

62537 - Home-use blood glucose monitoring system IVD

Ārstēšanas norādes:

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.

Autorizācija statuss:

A

Autorizācija datums:

2021-12-23