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(clin. chem. i-STAT) CONTROL PT/INR lvl 2, kit, 5+5 06P17-14

https://unicat.msf.org/cat/product/48860
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.
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 PT/INR

Definition

Control solution to be used with the i-STAT PT/INR cartridge. Level 1 is normal and Level 2 is abnormal.

Specifications

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Technical specifications

i-STAT PT controls, Levels 1 and 2, are contained in 6 ml vials. Separate 6 ml vials contain 1-3 mL of calcium chloride solution for reconstitution

Packaging & Labelling

Each level is composed of 5 vials of lyophilised human plasma + 5 vials of calcium chloride diluent (9.5 +/- 1.5 mmol/l)

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
  • Control solutions may also be stored at room temperature for up to 4 hours (18 to 30°C)
  • Do not keep a reconstituted solution. It must be used immediately

(Cf Introduction: Thermosensitive products)

Waste management

Dispose of this product as biohazardous waste according to all local, state, and
national regulations

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