Wellion AMADEUS

Primary DI

D-47136487603C3SY3

Basic UDI-DI Code

B-47136487603C3SY3

Reference

S5800475, S5800476, S5800477

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Apex Biotechnology Corp.

The purpose of the control solution test is to validate the performance of the blood glucose monitoring system. There are 2-3 different levels of control solution. Each has a different concentration of glucose, allowing you to check for test result accracy at low, normal and high glucose levels for any given batch of test strips. Results that are within the specified glucose concentration ranges confirm that the user's technique is appropriate and that the test strip and the meter are functioning properly. The blood glucose monitoring system used together with the control solution is plasma calibrated.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).