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(spectrophotometer) KIT,BILIRUBIN direct/total 2x100ml 10740

https://unicat.msf.org/cat/product/13502
STD ELAESPET10740

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Former Code(s): -X DDGTZBD0126 DDGTSPEP120
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.
W01010203 - Bilirubin
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.
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) KIT, BILIRUBIN D&T

Definition

Kit of reagents to determine the dosage of bilirubin in a blood sample (non hémolysed serum or heparinised plasma) with the use of a spectrophotometer, following the Jendrassik/Grof method.

To be used with the Humalyzer 2000 which allows testing of the main clincal chemistry and haematology tests, including bilirubine.

It replaces the Bilirubin kit (spectrophotometer), ref. 10012 (ELASPET10012).

Specifications

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Components

Contents of kit:

  • 1 x 100 ml Total bilirubin reagent (white cap)
    • Sulphanilic acid 14 mmol/l
    • Hydrochloric acid 300 mmol/l
    • Caffeine (accelerator) 200 mmol/l
    • Sodium benzoate 420 mmol/l
  • 1x 9 ml T-Nitrite reagent (white cap)
    • for determination of total bilirubin
    • Sodium nitrite (Xn, R22) 390 mmol/l
  • 1 x 100 ml Direct bilirubin reagent (blue cap)
    • Sulphanilic acid 14 mmol/l
    • Hydrochloric acid 300 mmol/l
  • 1 x 9 ml D-nitrite reagent (blue cap)
    • for determination of direct bilirubin
    • Sodium nitrite 25 mmol/l

Note: Both reagents and nitrite solutions are ready for use.

Technical specifications

  • Complete kit for 200 measurements (controls, standard, samples): 100 total bilirubin and 100 direct bilirubine
  • Colorimetric test, Jendrassik/Gróf method (546 nm)
  • Sample types: serum, heparinised plasma
  • Wavelength: 546 nm
  • Operating temperature: 20 to 25°C
  • Optical path: 1 cm

Packaging & Labelling

Kit with 2 vials of 100 ml, and 2 vials of 9 ml

To be Ordered Separately

  • Lyophilised control Serodos (Human): normal range, ref. 13951
  • Lyophilis control Serodos Plus (Human): abnormal range, ref. 13151

(see related articles below)

Instructions for use

Follow the instructions in 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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Storage

  • Do not freeze
  • Shelf life: 8 months
  • Not to be used beyond expiry date
  • Reagents are stable after opening if stored between 15 and 25°C

(Cf Introduction: Thermosensitive products)

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