(HemoCue HbA1c) CONTROL level 1, 10x0.1ml, 011.001.010

STD ELAECCHT802

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CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
W0101050205 - Diabetes controls
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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(clin.chem HemoCue HbA1c) KIT CONTROLS, 3 levels

Definition

3 level controls intended for the verification of the precision and accuracy of the Hemocue HbA1c analyzer.

Specifications

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Technical specifications

  • Hemolysed and lyophilised human blood.
  • Brown glass vial (0.1 mL) with lyophilisate and closed rubber stopper and colored cap.

Instructions for use

Frequency of use: Use the 3 control levels 1x per week

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

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Storage

  • Shelf life: 24 months
  • Storage: Unopened 2-8°C until expiry date.
  • After opening the vial and reconstitution of the material, it is stable for 48 hours stored at 2-8°C

(Cf Introduction: Thermosensitive products)

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