(spectrophotometer) KIT, CREATININE liquicolor 200 ml 10051

STD ELAESPET10051

Valid Article

Former Code(s): DDGTSPEPCRE
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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.
W01010207 - Creatinine
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.
The order of this product needs to be justified and is only acceptable under certain conditions.
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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) KIT, CREATININE

Note

This kit is stopped by the manufacturer in 2023, it remains available as long as the stock lasts. Please contact your laboratory advisor to identify an alternative.

The creatinine kit is again the Jaffé-reaction kit, replacing the enzymatic creatinine kit which is stopped because it is unpractical and hard to implement.

Definition

Kit of reagents to determine the dosage of creatinine in a blood sample (serum, heparinised plasma) or urine with the use of a spectrophotometer.

Specifications

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Components

  • 1 x 100 ml Picric Acid (26 mmol/l) (PIC)
  • 1 x 100 ml Sodium Hydroxide (1.6 mol/l) (NaOH)
  • 1 x 5 ml Standard (STD)

Technical specifications

  • Jaffé-reaction, photometric colorimetric test for kinetic measurement
  • Complete kit for 100 measurements (controls, standard, samples)
  • Controls should to be ordered separately

Packaging & Labelling

Kit with 2 vials of 100 ml and 1 vial of 5 ml

Transport Dangerous Goods

  • UN1824
  • Class: 8
  • Packing group: II
  • Proper shipping name: Sodium hydroxide solution mixture

To be Ordered Separately

  • Lyophylised control Serodos (Human) normal range and Serodos Plus (Human) abnormal range
  • Distilled water

Instructions for use

Follow the instructions in the leaflet.

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.

Caution

The Jaffé method is sensible for interfering substances like certain antibiotics. Contact your laboratory advisor for more information.

Note: The alternative creatinine enzymatic kit was stopped in the past because this method is unpractical and difficult to implement.

Storage

  • Store between 15 and 25°C
  • Do not freeze
  • Shelf life: 34 months
  • Not to be used beyond expiry date
  • Prepared reagent is stable 4 weeks at 15 to 25°C

(Cf Introduction: Thermosensitive products)

Classification EC Regulation N° 1272/2008

  • Metal Corrosive, Category 1; H290
  • Skin Corrosive Category 1A; H314
  • Eye Damage Category 1; H318
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Signal Word

Danger

H290May be corrosive to metals.
H314Causes severe skin burns and eye damage.
H318Causes serious eye damage.
P405Store locked up.
P310Immediately call a POISON CENTER or doctor/physician.
P303 + P361 + P353IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing.
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations
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