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les liquides organiques.

Il s’agit d’un dispositif de DIV destiné à être utilisé en combinaison avec des dosages de dépistage, de surveillance (aide à la surveillance) et de diagnostic (aide au diagnostic) du diabète.

Le trouble spécifique est couvert par les dosages applicables exécutés sur l’instrument. Le type d’échantillon à utiliser comprend le sérum, le plasma, le sang total et l’hémolysat utilisés pour détecter et/ou mesurer les analytes couverts par les dosages spécifiques.

Les utilisateurs prévus de ce dispositif sont les techniciens de laboratoire formés et les représentants service Roche formés (usage professionnel uniquement).", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" } ] } } ] }

cobas c 513 analyzer

Créer un précédent dans l'efficience du dosage de l'HbA1c

Analyseur cobas c 513
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Le cobas c 513 analyzer est un analyseur de chimie clinique intégralement automatisé et distinct destiné à la détermination quantitative in vitro d’analytes contenus dans les liquides organiques.
Dispositif médical de diagnostic in vitro. Classe A
Mandataire : Roche Diagnostics GmbH (Allemagne) – Distributeur : Roche Diagnostics France
Lire attentivement les instructions figurant dans le manuel d’utilisation.

Mis à jour : 03/2023

Aperçu

Commander

Documents techniques

Spécifications produit1

Avec une cadence allant jusqu’à 400 dosages d''HbA1c/heure sur sang total et tubes fermés, l’analyseur cobas c 513 assure un flux de travail entièrement automatisé et particulièrement efficient permettant de minimiser les interventions opérateur, et ce dès l’étape de chargement des échantillons.

 

Méthode Roche Tina-quant® HbA1c Gen.32

 

Le cobas c 513 utilise la méthode bien établie Tina-quant® HbA1c raccordée à la méthode IFCC et transférable au DCCT/NGSP pour garantir des résultats de haute qualité et standardisés.

Grâce à l'absence d'interférence vis-à-vis des variants courants et de la plupart des variants rares, le test Tina-quant® HbA1c Roche permet le diagnostic et le suivi des patients diabétiques, et fournit des résultats en lesquels les cliniciens et les patients peuvent faire confiance.

 

Des volumes d'activité importants

 

Une cadence allant jusqu'à 400 dosages d'HbA1c/heure sur tubes fermés et sang total et 600 tests/heure sur hémolysat.

 

Des flux de travail entièrement automatisés et très efficients

 

  • Des interventions opérateur minimisées depuis l'enregistrement échantillon jusqu'au rendu des résultats
  • L’échantillonnage sur tube fermé garantit la sécurité du personnel de laboratoire
  • Mélange préalable des échantillons non requis

 

Analyseur

 

  • Une cadence élevée pouvant atteindre 400 résultats par heure  
  • Une capacité de plus de 14 000 tests à bord sans rechargement
  • Échantillonnage sur tube fermé 
  • Appartient à la gamme cobas®, des dispositifs éprouvés et fiables 
  • cobas Link pour les services à distances

 

Réactifs

 

  • c pack (500 tests)
  • Test Tina-quant® HbA1c . Gen.32
  • Standardisés selon la méthode de référence IFCC, les résultats peuvent être exprimés en unités DCCT/NGSP
  • Résultats rendus sans étape intermédiaire (en unités IFCC et NGSP)

Références :

  1. Manuel utilisateur cobas c 513, v 6.0, 08/2021
  2. Fiche technique Tina-quant HbA1c Gén.3, v 4.0, 01/2022
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