CYANVision

Primary DI

05404035100288

Basic UDI-DI Code

54040351CY0145V

Reference

CY014

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Cypress Diagnostics

The CYANVision semi-automatic analyzer is an in-vitro diagnostic medical device for professional use only. (Semi-) automatic biochemistry analyzers are widely applied in hospitals and research institutes for the quantitative determination of different biochemical substances and other characteristics in various biological samples. Evaluation of these measured properties of blood and other fluids may be useful in the diagnosis of disease. The type of in vitro diagnostic tests that can be performed on this analyzer includes enzyme levels (such as many of the liver function tests), ion levels (e.g. sodium and potassium), and other tell-tale chemicals (such as glucose, serum albumin, or creatinine). Enzymes may be measured by the rate they change one colored substance to another; in these tests, the results for enzymes are given as an activity, not as a concentration of the enzyme. Other tests use colorimetric changes to determine the concentration of the chemical in question. Turbidity may also be measured. For the best results, we advise using Cypress Diagnostics reagents. The analyzer is delivered with all Cypress Diagnostics biochemistry test methods pre-programmed. These methods have been extensively verified and optimized. In the application sheets, you can find detailed information on the preparation of the samples and the execution of the tests for all Cypress Diagnostics kits. Using these pre-programmed methods and following the preparation instructions correctly, Cypress Diagnostics guarantees the accuracy and precision as stated in the kit’s insert.

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 A) and regulation (EU IVDR).