Glucose (HK)

Primary DI

16438153813047

Basic UDI-DI Code

6438153BU00056BU

Reference

981304

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of glucose concentration in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The glucose test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of carbohydrate disorders, such as diabetes mellitus, or hypoglycemia of various reasons, in patients.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).