(clinical chem. i-STAT) CONTROL PT/INR level 2, 06P17-14

STD ELAECCHT118

Valid Article

Former Code(s): ELAEZBE0830
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.
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 PT/INR

CAUTION

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

Definition

Control solution to be used with the i-STAT PT/INR cartridge.

Specifications

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Components

  • 10 vials of 1.7 ml PT Control Level 1
  • 10 vials of 1.7 ml PT Control Level 2

Packaging & Labelling

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

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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