ZAF-101

Nom de l'organisation

Zafena AB

SRN

SE-MF-000024138

Statut du fabricant

Actif

Marché principal en Suède ; disponible dans 4 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07333051101109

Basic UDI-DI

B-07333051101109

Numéro de référence/catalogue

ZAF-101

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

Simple Simon® PT [ZAF-101] – near patient PT INR according to Owren method performed at ambient room temperature Simple Simon® PT measures prothrombin complex (PK) in INR. Simple Simon® PT (SSPT) is intended for in-patient analysis of prothrombin time expressed in INR (PT-INR). The analyte is also called prothrombin complex activity (PK) or tissue factor-induced coagulation time. SSPT is intended for smaller laboratories at hospitals, health centers, medical stations and doctors’ offices. The product can contain ZAF-103 MixxoCap® and has IT support when the product is used with ZAF-552 Zafena POC-Workstation and ZAF-550 Connector. The Simple Simon concept ® is for patient-centered, wet chemical laboratory diagnostics. Simple Simon® is “all-in-one”. Reagents, calibrated reader (measuring unit) and other are in the same product. Reagents and other things have the same lot number and the same expiration date as the reader. Along with each reagent lot comes a factory-controlled, calibrated, “ready-to-use” reader.

URL des informations complémentaires

https://www.zafena.se/product/zafena-101-simple-simon-pt/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0103020801PROTHROMBIN TIME RT & POC

Ce dispositif n'est actuellement lié à aucun autre dispositif.