CYANHemato 380

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

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

Dénomination commerciale

CYANHemato 380

Code d'UDI-DI

05404035100486

Basic UDI-DI

B-05404035100486

Numéro de référence/catalogue

CY017

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The CYANHemato 380 (CY017) is an easy to operate, fully automated bench top hematology analyzer designed for in vitro diagnostic testing. It is intended to be used by trained healthcare professionals only, in clinical laboratories. The analyzer is a 3-part differential analyzer. It measures and evaluates the complete blood count (CBC) and differentiates the white blood cells in three populations: the lymphocytes, the mid-sized cells (reflecting monocytes) and the granulocytes (reflecting neutrophils, eosinophils, and basophils). The analyzer combines different techniques to analyze the whole blood samples: electrical impedance and spectrophotometry. The analyzer is intended to be used for the quantitative measurement and determination of the following 20 parameters in open vials with K2 or K3 EDTA-anticoagulated human venous whole blood samples: WBC, LYM, LYM%, MID, MID%, GRA, GRA%, HGB, RBC, MCV, HCT, MCH, MCHC, RDW, PLT, MPV, PCT, PDW, PLCC, PLCR. The CYANHemato 380 measures these hematologic parameters within and outside established reference ranges. The results provided by the CYANHemato 380 are for the evaluation of the patient's overall health (screening) and as an aid to diagnose and monitor a wide range of blood-related disorders.

URL des informations complémentaires

https://www.diagnostics.be/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0202010201AUTOMATED 3 PART HEMATOLOGY ANALYSERS

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel