(clinical chem. NycoCard II) CALIBRATION DEVICE 1116821

STD ELAECCHC311

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).
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0201069085 - Various rapid test chemistry / immunochemistry instruments - consumables
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.
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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(clinical chemistry NycoCard II) CONSUMABLES

Definition

Different consumables to be used with NycoCard: calibration device, pen ring, pen tip, capillary tubes and capillary holder.

Specifications

  • Capillary holder:
    • length 5.5 cm - wide 1.8 cm
  • Capillary tube:
    • 5 µL - 200 units
  • Calibration device:
    • for white calibration, to be realised on regular basis
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Packaging & Labelling

  • Capillary tubes: 200 tubes
  • Pen rings, pen tips, calibration device : 10 units
  • Capillary holder: 1 unit

Instructions for use

Follow the instruction and maintenance manuals

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.

Storage

​Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

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