CYANVision

Nom de l'organisation

Cypress Diagnostics

SRN

BE-MF-000000033

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  see IFU

Marché principal en Belgique ; disponible dans 1 pays au total.

Commercialisé en Belgique ; dates par pays non publiées.

Dénomination commerciale

CYANVision

Code d'UDI-DI

05404035100288

Basic UDI-DI

54040351CY0145V

Numéro de référence/catalogue

CY014

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe A

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W02010199CHEMISTRY INSTRUMENTS - OTHER

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