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(clinical chem. i-STAT) CONTROL, level 1 05P71-01

https://unicat.msf.org/cat/product/13255
STD ELAECCHT111

Valid Article

Former Code(s): -X SLASANAL111 SLASZNL0172
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.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01010501 - Multicomponent controls (clinical chemistry)
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
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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(clinical chemistry i-STAT) KIT CONTROLS

CAUTION

This control is worded and codified by unit to make the order easier but is always packaged in kit of 10.

Definition

Three levels of control solutions to be used with following i-STAT analyser cartridges:

  • CARTRIDGE E3+
  • CARTRIDGE EC8+
  • CARTRIDGE Creatinine
  • CARTRIDGE Chem8+
  • CARTRIDGE EC4+
  • CARTRIDGE EG7+

Specifications

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Components

  • 10 vials of 1.7 ml TriControls Control Level 1
  • 10 vials of 1.7 ml TriControls Control Level 2
  • 10 vials of 1.7 ml TriControls Control Level 3

Packaging & Labelling

Each level of control is packed in a box containing 10 individual 1.7ml glass ampules.

Instructions for use

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

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

(Cf Introduction: Thermosensitive products)

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