(clin.chem.Piccolo) KIT 10 CONTROLS,level 2 high A1100-9132E

STD ELAECCHT412

Valid Article

Former Code(s): SLASMISC379 SLASZFR0379
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.
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 Piccolo) KIT CONTROLS

Definition

Piccolo xpress controls are to be used with the Piccolo Xpress chemistry analyserand the reagent discs. It covers all Piccolo Xpress parameters (including CRP).

Specifications

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Technical specifications

  • lyophilised control vials: 10 x 1 ml
    • kit level 1 (low): blue top
    • kit level 2 (high): red top
  • diluent vials: 10 x 1 ml

Packaging & Labelling

Box of 20 vials of 10 ml

Instructions for use

Follow instructions on package insert and/or operating 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

  • Temperature between 2 and 8°C
  • Shelf life: minimum of 2 years
  • Stability after reconstitution: 7 days between 2 and 8 ºC

(Cf Introduction: Thermosensitive products)

MSF requirements

Chemistry controls level 1 (low) and level 2 (high) produced specifically for use with the clinical chemistry analyser Piccolo Xpress.

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