(clinical chem. i-STAT) cTnI TROPONIN I CARTRIDGE, 03P90-25

STD ELAECCHT119

Valid Article

Former Code(s): DDGTZBE0241
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.
7
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01021306 - Troponin i/t
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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(clinical chemistry i-STAT) CARTRIDGE cTnI TROPONIN

Definition

Single use cardiac troponin I (cTnI) cartridge to be used with i-STAT for the quantitative determination of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I is used in the diagnosis and treatment of acute myocardial infarction and cardiac muscle lesions.

Specifications

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Technical specifications

  • 1 cartridge is aimed to perform the tests for 1 patient.

Packaging & Labelling

Box of 25 cartridges

To be Ordered Separately

  • Control solutions cTnI; level 1, 2 and 3 (see related items)

Instructions for use

Follow the instructions manual

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: 7 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

(Cf Introduction: Thermosensitive products)

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