Home-use blood glucose monitoring system IVD
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
17-01-2022
अनुरोध भेजा।
थमां उपलब्ध:
Silverline Medical Pty Ltd
वर्ग:
Class IIa
द्वारा बनाया गया:
Tyson Bioresearch Inc 5F No 16 18 20 22 Kedong 3rd Road, Zhunan Township, Miaoli County, 35053 Taiwan
चिकित्सीय क्षेत्र:
62537 - Home-use blood glucose monitoring system IVD
चिकित्सीय संकेत:
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.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2021-12-23
