2in1 Max Blood Glucose Test Strips

Dénomination commerciale

2in1 Max Blood Glucose Test Strips

Code d'IUD-ID

06937339206909

IUD-ID de base

B-06937339206909

Numéro de référence/catalogue

VGS02-038

Entité d'attribution

GS1

Catégorie de risque

IVDD — Annexe II Liste B

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 2in1. Max Blood Glucose Test Strips are thin strips with a chemical reagent system. They work with the 2irh1. Max and MaX BT Blood Glucose Meters as a system to quantitatively measure the glucose concentration in fresh capillary whole blood. The 2in1. MaX / MaX BT blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed. The meter is calibrated to display plasma-like concentration results. The 2in1. MaX and MaX BT Blood Glucose Monitoring Systems are fully complying with the new EN ISO 15197:2015 International Standard. The 2in1. Max Blood Glucose Test Strips and 2in1. Max and MaX BT Blood Glucose Meters are intended for use outside the body (in vitro diagnostic use) for self-testing and health care professional use, as an aid to monitor the effectiveness of diabetes control. The system should not bee used for diagnosis of diabetes. Professionals may also test neonatal, venous and arterial blood samples.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• W0101060101GLUCOSE TEST STRIPS

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

• CW010

  EUDAMED n'a pas publié de description pour ce code.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.