CYANVision

Organization name

Cypress Diagnostics

SRN

BE-MF-000000033

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  see IFU

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Trade name

CYANVision

UDI-DI code

05404035100288

Basic UDI-DI

54040351CY0145V

Reference / catalog number

CY014

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02010199CHEMISTRY INSTRUMENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification