(spectrophotometer) KIT, UREA, Liquicolor, 2x100ml 10505

STD ELAESPET10505

Valid Article

Former Code(s): -X SLASZTF0356 DDGTZBD0125 DDGTZNL0014

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.
W01010204 - Urea/blood urea nitrogen
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) KIT, UREA

Definition

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

Specifications

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Components

  • 1 x 100 ml Reagent 1 (RGT 1)
    • Phosphate buffer (pH 7.0) 120 mmol/l
    • Sodium salicylate 60 mmol/l
    • Sodium nitroprusside 5 mmol/l
    • EDTA 1 mmol/l
  • 1 x 100 ml Reagent 2 (RGT 2)
    • Phosphate buffer (pH < 13) 120 mmol/l
    • Hypochlorite ≈ 0.6 g/l C
  • 1 x 1 ml Urease Enzyme (ENZ)
    • Urease > 500 KU/l
  • 1 x 3 ml Standard (STD)
    • Urea see label
    • Sodium azide 0.095 %

Technical specifications

  • Complete kit for 100 measurements (controls, standard, samples)
  • Enzymatic colorimetric test for urea
  • Reagents RGT2 and STD are ready to use
  • Sample: serum, plasma except ammonium heparinate plasma, and urine

Packaging & Labelling

Kit of 2 bottles of 100 ml, one bottle of 1 ml and one of 3 ml

To be Ordered Separately

Lyophylised control Serodos (Human) normal range and Serodos Plus (Human) abnormal range (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

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 12 months
  • Not to be used beyond expiry date
  • (RGT1), (RGT2) and (ENZ) are stable 6 weeks at 2 to 8°C after opening or 2 weeks at 15 to 25°C
  • (Prepared ENZ reagent - RGT1/ENZ) is stable 4 weeks at 2 to 8°C or 2 weeks at 15-25°C
  • (STD) are stable up to expiry date

(Cf Introduction: Thermosensitive products)

Signal Word

Danger (RGT 2)

H290May be corrosive to metals.
H314Causes severe skin burns and eye damage.
H412Harmful to aquatic life with long lasting effects
P401Store in accordance with local and regional/ national/ international regulations
P234Keep only in original container.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P262Do not get in eyes, on skin, or on clothing.
P281Use personal protective equipment as required.
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
P337 + P313If eye irritation persists: get medical advice/attention
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations
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