(clin.chem HemoCue HbA1c) TEST CARTRIDGE, 405110

STD ELAECCHT801

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01010214 - Glycosylated/glycated haemoglobin (cc)
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.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(clin.chem HemoCue HbA1c) TEST CARTRIDGE

Definition

Single use cartridge to be used with Hemocue HbA1c for quantitative determination of the percentage of Haemoglobin A1c (HbA1c %) in capillary and anticoagulated venous whole blood samples.

Specifications

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Technical specifications

  • single use cartridge for HbA1c %
  • whole blood sample

Packaging & Labelling

Box of 10 single packaged cartridges

Instructions for use

Recommendations cartridge filling procedure (see image below):

  • Insufficient blood volume can happen if an air bubble is introduced thereby hindering blood to be collected
  • It is important that the capillary is kept in the blood drop until filled
  • Excess blood should NOT be wiped off for the HbA1c method (NOTE: this is different from the Hemocue 201 and 301 methods where excess blood is wiped off)

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

  • Store cartridges at 2-32°C.
  • Do not freeze
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
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