(spectro) CONTROL SERODOS PLUS (Human) abnormal 6 x 5 ml

STD ELAESPET13151

Valid Article

Former Code(s): SLASSPEP002
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.
W0101050101 - Assayed multicomponent controls (cc)
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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(spectrophotometer) CONTROL SERODOS (Human)

Definition

Lyophilised control serum (2 levels; normal and abnormal) based on human serum with values assayed for all important components of human serum.

Used for the internal quality control in biochemistry when using the spectrophotometer and the tests.

Specifications

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Packaging & Labelling

6 vials of 5 ml

Instructions for use

SERODOS and SERODOS Plus need to be reconstituted in distilled water 30 min before use. Follow the package insert.

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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Precautions for Use

SERODOS and SERODOS Plus are obtained from human blood and potentially infectious.

Storage

  • Unopened vials: keep refrigerated between 2 and 8ºC until expiry date
  • Reconstituted vials:
    • keep refrigerated between 2 and 8ºC
    • Details on stability, please consult the instruction for use
    • Note that the stability varies depending on the parameter
  • Freshly dissolved SERODOS and SERODOS Plus can be divided into portions and frozen once (-20°C) for at least 1 month.
  • Dissolved SERODOS/ SERODOS Plus is light sensitive.
  • Shelf life:
    • SERODOS PLUS anormal: 36 months.
    • SERODOS normal: 22 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

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