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(Erba XL200) REAGENT KIT UREA XSYS0020

https://unicat.msf.org/cat/product/73626
STD ELAECCHC718

Valid Article

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.
0208
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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(Erba XL200) REAGENT KIT UREA , XSYS0020

Definition

Reagent for quantitative in vitro determination of urea (Urease GLDH method) in human serum, plasma et urine using an Erba XL chemistry automate.

Specifications

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Components

R1:

  • Tris buffer 100 mmol/l
  • α-ketoglutarate 5.49 mmol/l
  • Urease (Jean Bean) >= 10 KU/l
  • GLDH (microorganism) >= 3.8 KU/l

R2:

  • NADH 1.66 mmol/l
  • Also contains non-reactive fillers and stabilisers

Technical specifications

  • Ready to use
  • R1, STD : Clear colourless liquid
  • R2: liquid
  • 1250 tests
  • Sample: non heamolysed serum, plasma or urine. Do not use sample preserved with fluoride and heparin ammonium salt as anticoagulant

Packaging & Labelling

R1: 5 x 44 ml - R2: 5 x 11 ml

Transport Dangerous Goods

Transport not regulated

To be Ordered Separately

  • Quality controls
  • Calibrators

Instructions for use

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Storage

  • The unopened reagents are stable till the expiry date stated on the bottle and kit label when stored at 2–8°C.
  • On board stability: minimum 30 days if refrigerated (2–10°C) and not contaminated.

Classification EC Regulation N° 1272/2008

Not classified as hazardous

MSF requirements

Use with the Erba XL200

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