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(clin. chem. i-STAT) CONTROL PTPlus lvl 2, kit, 5+5 06P17-18

https://unicat.msf.org/cat/product/96430
NST ELAECCHT140

Valid Article

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
W010304080501 - Hemostasis controls RT & POC
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)
https://unicat.msf.org/web/image/product.template/587905/image_1920?unique=2a6e301

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(clinical chemistry i-STAT) KIT CONTROLS PT Plus

Definition

Two levels of control solution for PT and INR tests, to be used with the i-STAT PT Plus cartridge. Level 1 is normal/non-therapeutic and Level 2 is abnormal/therapeutic.

Specifications

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Technical specifications

  • i-STAT PT Plus controls, Levels 1 and 2 are composed of lyophilised plasma and CaCl2
  • Lyophilised pellet, solid, straw yellow
  • Solution liquid, blue

Dimensions

Box of 1 level control: 4.4 (H) x 11.7 (L) x 4.8 cm (P)

Packaging & Labelling

10 glass vials/box: Each level is composed of 5 vials of lyophilised human plasma + 5 vials of calcium chloride diluent

Transport Dangerous Goods

Transport not regulated

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 before reconstitution (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

Classification EC Regulation N° 1272/2008

Not classified as hazardous

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Description validated by the OCB referent (Pascale Chaillet) in April 2025